Cardiac Valve Annuloplasty, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Regurgitation
Conditions
Keywords
Valtech Cardio, Cardioband, Tricuspid
Brief summary
The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement. TR can worsen or appear late after successful mitral valve surgery which portends a poor prognosis. However, standard surgical approaches requiring cardiopulmonary bypass and especially second surgery have an excessive risks. Thus many patients are denied surgery because of unfavorable risk-benefit balance. Therefore there is a need for novel devices enabling interventional cardiologists and cardiothoracic surgeons to perform tricuspid annuloplasty by transcatheter methods. Cardioband replicates established surgical techniques (e.g., annuloplasty) using transfemoral approach, without sutures and with adjusted on the beating heart. Similar to the approved indication for mitral annuloplasty. The Cardioband System is expected to allow for treatment of patients that would otherwise not undergo Tricuspid valve repair due to the invasiveness of current techniques.
Detailed description
The Cardioband Transcatheter System (Cardioband) is a marketed system that was approved for treatment of secondary (functional) mitral regurgitation (FMR) (CE granted on September 2015). The Cardioband is an annuloplasty band that is similar to a surgical annuloplasty, however deployed on the beating heart through a transvenous approach. The CE mark study with 30 subjects has been completed and documented significant reduction of severity of MR and improvement in quality of life by Minnesota living with heart failure questionnaire (MLHFQ), New York Heart Association (NYHA) and 6- minute walk test (6MWT), in subjects with moderate to severe MR. The aim of the current study is to evaluate the Cardioband annuloplasty system for repair the Tricuspid Regurgitation.
Interventions
DEVICECardioband Tricuspid
The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Chronic functional tricuspid regurgitation (FTR) with annular diameter ≥ 40 mm with valve Systolic pulmonary pressure (sPAP) ≤ 60mmHg 2. ≥18 years old 3. New York Heart Association (NYHA) Class II-IVa 4. Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen 5. LVEF ≥ 30% 6. Patient is willing and able to comply with all specified study evaluations 7. The Local Site Heart Team concur that surgery will not be offered as a treatment option 8. Transfemoral access of the Cardioband is determined to be feasible
Exclusion criteria
1. Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation ≥ moderate 2. Severe uncontrolled hypertension (Systolic BP ≥ 180 mmHg and/or Diastolic BP ≥ 110 mm Hg) 3. Previous tricuspid valve repair or replacement 4. Trans-tricuspid pacemaker or defibrillator leads suggesting impingement of the of the tricuspid valve leaflets, as evaluated by echocardiography 5. Active endocarditis 6. MI or known unstable angina within the 30 days prior to the index procedure 7. Any percutaneous coronary intervention (PCI) or transcatheter valvular intervention within 30 days prior to the index 8. Hemodynamic instability or on IV inotropes 9. Cerebrovascular Accident (CVA) within the past 6 months 10. Subject is on chronic dialysis 11. Anemia (Hb \< 9 g/dL) not corrected by transfusion 12. Bleeding disorders or hypercoaguable state 13. Active peptic ulcer or active gastrointestinal (GI) bleeding 14. Contraindication to anticoagulants 15. Known allergy to stainless steel, nickel, and/or polyester 16. Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure 17. In the judgment of the Investigator, co-morbid condition(s) that could limit the subject's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study 18. Life expectancy of less than 12 months 19. Impaired judgment and/or is undergoing emergency treatment 20. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study 21. intra-cardiac masses, thrombi or vegetations 22. Patients with cardiac cachexia 23. Subjects in whom transesophageal echocardiography is contraindicated 24. . Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically 25. Untreated clinically significant CAD requiring revascularization 26. Echocardiographic evidence of severe right ventricular dysfunction 27. Any coronary or endovascular surgery, within 3 months prior to procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE) | 30 days | Overall rate of Major Serious Adverse Events (MSAEs)\* and serious adverse device effects (SADE) |
| Access, Deployment and Positioning of the Cardioband Device | Intra-procedure | Successful access, deployment and positioning of the Cardioband device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tricuspid Regurgitation [Full Analysis Data Set] | 1, 6, 12, and 24 months over baseline | All data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, Severe. Data analysis per core lab. |
| Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up] | 1, 6, 12, and 24 months over baseline | Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab |
| Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set] | 1, 6, 12, and 24 months over baseline | All data available for Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab. |
| Regurgitant Volume [Paired Baseline and Follow-Up] | 1, 6, 12, and 24 months over baseline | Regurgitant Volume (by Echocardiography) data available at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab. |
| Regurgitant Volume [Full Analysis Data Set] | 1, 6, 12, and 24 months over baseline | All data for Regurgitant Volume (by Echocardiography) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab. |
| TAPSE [Paired Baseline and Follow-Up] | 1, 6, 12, and 24 months over baseline | Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab. |
| TAPSE [Full Analysis Data Set] | 1, 6, 12, and 24 months over baseline | All data for Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analyses based on core lab assessment. |
| NYHA [Paired Baseline and Follow-Up] | 1, 6, 12, and 24 months over baseline | NYHA classification data available at 1 month, 6 months, 12 months, 24 months over baseline. Measure Description: NYHA Classification - The stages of heart failure: 1. Class I - No symptoms and no limitation in ordinary physical activity 2. Class II - Mild symptoms and slight limitation during ordinary activity. 3. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. 4. Class IV - Severe limitations. Experiences symptoms even while at rest. |
| NYHA [Full Analysis Data Set] | 1, 6, 12, and 24 months over baseline | All data available for NYHA classification at 1 month, 6 months, 12 months, and 24 months over baseline. Measure Description: NYHA Classification - The stages of heart failure: 1. Class I - No symptoms and no limitation in ordinary physical activity 2. Class II - Mild symptoms and slight limitation during ordinary activity. 3. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. 4. Class IV - Severe limitations. Experiences symptoms even while at rest. |
| 6MWT [Paired Baseline and Follow-Up] | 1, 6, 12, and 24 months over baseline | Distance in meters walked during 6 Minute Walk Test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline. |
| 6MWT [Full Analysis Data Set] | 1, 6, 12, and 24 months over baseline | Distance in meters walked during 6 minute walk test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline. |
| Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up] | 1, 6, 12, and 24 months over baseline | The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status. |
| Technical Success | 1, 6, 12, and 24 months | Successful access, deployment and positioning of the Cardioband device and septolateral reduction. |
| Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up] | 1, 6, 12, and 24 months over baseline | Left ventricle ejection fraction data available for 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis based on core lab assessment. |
| Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set] | 1, 6, 12, and 24 months over baseline | All available data for left ventricle ejection fraction at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per echo core lab. |
| Left Ventricle End Diastolic Volume Index (LVEDVI) [Full Analysis Data Set] | 1, 6, 12, and 24 months over baseline | Left ventricle end diastolic volume index data available for 1 month, 6 months, 12 months, and 24 months over baseline. |
| Left Ventricle End Systolic Volume Index (LVESVI) [Full Analysis Data Set] | 1, 6, 12, and 24 months over baseline | Left ventricle end systolic volume index data available at 1 month, 6 months, 12 months, and 24 months over baseline. |
| NT-pro BNP [Full Analysis Data Set] | 1, 6, 12, and 24 months over baseline | N-terminal prohormone of brain natriuretic peptide data available at 1 month, 6 months, 12 months, and 24 months over baseline. |
| Diuretic Therapy | 1, 6, 12, and 24 months over baseline | Diuretic Therapy data available at 1 month, 6 months, 12 months, and 24 months over baseline. |
| Bilirubin [Full Analysis Data Set] | 1, 6, 12, and 24 months over baseline | Bilirubin data available at 1 month, 6 months, 12 months, and 24 months over baseline. |
| Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set] | 1, 6, 12, and 24 months over baseline | All available data for Blood urea nitrogen (BUN) and Serum Creatinine at 1 month, 6 months, 12 months, and 24 months over baseline. |
| Activity by Wearable Device | 1, 6, 12, and 24 months over baseline | Activity by wearable device available data at 1 month, 6 months, 12 months, and 24 months over baseline. |
| Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set] | 1, 6, 12, and 24 months over baseline | All data available for Glutamic oxaloacetic transaminase (GOT) and Aspartate Transaminase (AST) at 1 month, 6 months, 12 months, and 24 months over baseline. |
| Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set] | 1, 6, 12, and 24 months over baseline | All data available for glutamic pyruvic transaminase (GPT) Alanine Transaminase (ALT) at 1 month, 6 months, 12 months, and 24 months. |
| Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set] | 1, 6, 12, and 24 months over baseline | The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status. |
| Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 1, 6, 12, and 24 months over baseline | Data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, and Severe. Data analysis per core lab. |
Countries
France, Germany, Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cardioband Tricuspid Procedure Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 9 |
| Overall Study | Withdrawal by Subject | 1 |
| Overall Study | Withdrawal to non-compliance | 1 |
Baseline characteristics
| Characteristic | Cardioband Tricuspid Procedure | — |
|---|---|---|
| Active Malignancy | 0 Participants | — |
| Age, Continuous | 76.6 years STANDARD_DEVIATION 6.6 | — |
| Angina Pectoris | 0 Participants | — |
| Any Cardiac Device with Electrodes CRT-D Implant | 1 Participants | — |
| Any Cardiac Device with Electrodes CRT Implant | 0 Participants | — |
| Any Cardiac Device with Electrodes Dual Chamber Pacemaker Implant | 3 Participants | — |
| Any Cardiac Device with Electrodes ICD Implant | 2 Participants | — |
| Any Cardiac Device with Electrodes Single Chamber Pacemaker Implant | 1 Participants | — |
| Any Cardiac Device without Electrodes LAA Closure | 2 Participants | — |
| Any Cardiac Device without Electrodes Parachute Implant | 0 Participants | — |
| Any Cardiac Device without Electrodes PFO Closure | 1 Participants | — |
| Aortic Valve Moderate Regurgitation | 0 Participants | — |
| Aortic Valve Moderate Stenosis | 0 Participants | — |
| Aortic Valve None | 40 Participants | — |
| Aortic Valve Severe Regurgitation | 0 Participants | — |
| Aortic Valve Severe Stenosis | 0 Participants | — |
| Atrial Flutter/Fibrillation Chronic | 12 Participants | — |
| Atrial Flutter/Fibrillation None | 3 Participants | — |
| Atrial Flutter/Fibrillation Paroxysmal | 5 Participants | — |
| Atrial Flutter/Fibrillation Persistant | 20 Participants | — |
| CABG Double | 3 Participants | — |
| CABG Single | 3 Participants | — |
| CABG Triple/Quadruple/Quintuple | 2 Participants | — |
| Calculated BMI | 25.0 kg/m^2 STANDARD_DEVIATION 3.9 | — |
| Carotid Intervention | 0 Participants | — |
| Carotid Surgery | 1 Participants | — |
| Chronic Anemia | 5 Participants | — |
| Chronic Liver Disease Moderate | 0 Participants | — |
| Chronic Liver Disease None/Mild | 40 Participants | — |
| Chronic Liver Disease Severe | 0 Participants | — |
| Chronic Lung Disease (Moderate to Severe) | 11 Participants | — |
| Chronic Renal Disease | 22 Participants | — |
| Congestive Heart Failure | 25 Participants | — |
| Coronary Artery Disease | 17 Participants | — |
| Diabetes | 10 Participants | — |
| Dyslipidemia | 22 Participants | — |
| Elevated Pulmonary Pressure (> 35mmHG) | 19 Participants | — |
| Estimated Glomerular Filtration (eGFR) | 46.3 mL/min/1.73m^2 STANDARD_DEVIATION 17.6 | — |
| EUROSCORE II | 4.4 Score STANDARD_DEVIATION 2.9 | — |
| Flutter/Fibrillation Ablation | 8 Participants | — |
| Frailty Score Apparently Vulnerable (4) | 6 Participants | — |
| Frailty Score Mildly Frail (5)/Moderately Frail (6) | 20 Participants | — |
| Frailty Score Severely Frail (7) | 0 Participants | — |
| Frailty Score Very Fit (1) | 0 Participants | — |
| Frailty Score Well (2)/Well with Treated Comorbid Disease (3) | 14 Participants | — |
| FTR Etiology Ischemic | 7 Participants | — |
| FTR Etiology Non-ischemic | 33 Participants | — |
| History of Endocarditis | 1 Participants | — |
| History of Smoking Current | 3 Participants | — |
| History of Smoking None | 26 Participants | — |
| History of Smoking Past | 11 Participants | — |
| Left Ventricle Ejection Franction (LVEF) % | 56.9 Percent Fraction STANDARD_DEVIATION 10.2 | — |
| Mitral Valve Moderate Regurgitation | 0 Participants | — |
| Mitral Valve Moderate Stenosis | 0 Participants | — |
| Mitral Valve None | 40 Participants | — |
| Mitral Valve Severe Regurgitation | 0 Participants | — |
| Mitral Valve Severe Stenosis | 0 Participants | — |
| NYHA Class II | 6 Participants | — |
| NYHA Class III | 32 Participants | — |
| NYHA Class IV | 2 Participants | — |
| NYHA Class Grouped I/II | 6 Participants | — |
| NYHA Class Grouped III/IV | 34 Participants | — |
| Ongoing Inotropic Support | 0 Participants | — |
| Other Relevant Medical Conditions | 32 Participants | — |
| Percutaneous Coronary Intervention | 8 Participants | — |
| Percutaneous Transcatheter Valve Replace/Repair other than Tricuspid Mitraclip | 4 Participants | — |
| Percutaneous Transcatheter Valve Replace/Repair other than Tricuspid Other | 0 Participants | — |
| Percutaneous Transcatheter Valve Replace/Repair other than Tricuspid Transcatheter Aortic Valve Implantation | 0 Participants | — |
| Peripheral Vascular Disease | 7 Participants | — |
| Peripheral Vascular Intervention | 0 Participants | — |
| Previous MI | 2 Participants | — |
| Prior Stroke | 4 Participants | — |
| Prior Transient Ischemic Attack | 2 Participants | — |
| Pulmonary Pressure | 36.5 mmHg STANDARD_DEVIATION 11.5 | — |
| Pulmonic Valve Moderate Regurgitation | 0 Participants | — |
| Pulmonic Valve Moderate Stenosis | 0 Participants | — |
| Pulmonic Valve None | 40 Participants | — |
| Pulmonic Valve Severe Regurgitation | 0 Participants | — |
| Pulmonic Valve Severe Stenosis | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 29 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
| STS Score | 2.8 Percentage of expected mortality STANDARD_DEVIATION 1.5 | — |
| Systemic Hypertension | 33 Participants | — |
| Thyreosis Hyperthyreosis | 0 Participants | — |
| Thyreosis Hypothyreosis | 12 Participants | — |
| Valve Surgery Aortic Valve | 1 Participants | — |
| Valve Surgery Mitral and Aortic Valve | 1 Participants | — |
| Valve Surgery Mitral Valve | 4 Participants | — |
| Valve Surgery Other | 0 Participants | — |
| Ventricular Tachyarrhthmia None | 38 Participants | — |
| Ventricular Tachyarrhthmia Non-sustained | 0 Participants | — |
| Ventricular Tachyarrhthmia Sustained | 1 Participants | — |
| Ventricular Tachyarrhthmia VF | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 40 |
| other Total, other adverse events | 34 / 40 |
| serious Total, serious adverse events | 33 / 40 |
Outcome results
Primary
Access, Deployment and Positioning of the Cardioband Device
Successful access, deployment and positioning of the Cardioband device
Time frame: Intra-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardioband Tricuspid Procedure | Access, Deployment and Positioning of the Cardioband Device | 39 Participants |
Primary
Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE)
Overall rate of Major Serious Adverse Events (MSAEs)\* and serious adverse device effects (SADE)
Time frame: 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cardioband Tricuspid Procedure | Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE) | MSAE | 3 Participants |
| Cardioband Tricuspid Procedure | Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE) | SADE | 1 Participants |
Secondary
6MWT [Full Analysis Data Set]
Distance in meters walked during 6 minute walk test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | 6MWT [Full Analysis Data Set] | Baseline | 221.9 Meters | Standard Deviation 113 |
| Cardioband Tricuspid Procedure | 6MWT [Full Analysis Data Set] | 1 Month | 289.4 Meters | Standard Deviation 118.7 |
| Cardioband Tricuspid Procedure | 6MWT [Full Analysis Data Set] | 6 Months | 279.2 Meters | Standard Deviation 130.6 |
| Cardioband Tricuspid Procedure | 6MWT [Full Analysis Data Set] | 12 Months | 273.6 Meters | Standard Deviation 133.4 |
| Cardioband Tricuspid Procedure | 6MWT [Full Analysis Data Set] | 24 Months | 288.2 Meters | Standard Deviation 120.2 |
Secondary
6MWT [Paired Baseline and Follow-Up]
Distance in meters walked during 6 Minute Walk Test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline and 1 month, 6 months, 12 months, and 24 months is 29, 28, 25, and 17 respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | 6MWT [Paired Baseline and Follow-Up] | Baseline (1 Month) | 232.0 Meters | Standard Deviation 117.5 |
| Cardioband Tricuspid Procedure | 6MWT [Paired Baseline and Follow-Up] | 1 Month | 289.4 Meters | Standard Deviation 118.7 |
| Cardioband Tricuspid Procedure | 6MWT [Paired Baseline and Follow-Up] | Baseline (6 Months) | 236.1 Meters | Standard Deviation 107.8 |
| Cardioband Tricuspid Procedure | 6MWT [Paired Baseline and Follow-Up] | 6 Months | 280.6 Meters | Standard Deviation 132.8 |
| Cardioband Tricuspid Procedure | 6MWT [Paired Baseline and Follow-Up] | Baseline (12 Months) | 222.2 Meters | Standard Deviation 104.7 |
| Cardioband Tricuspid Procedure | 6MWT [Paired Baseline and Follow-Up] | 12 Months | 273.6 Meters | Standard Deviation 133.4 |
| Cardioband Tricuspid Procedure | 6MWT [Paired Baseline and Follow-Up] | Baseline (24 Months) | 211.6 Meters | Standard Deviation 124.9 |
| Cardioband Tricuspid Procedure | 6MWT [Paired Baseline and Follow-Up] | 24 Months | 294.3 Meters | Standard Deviation 121 |
Secondary
Activity by Wearable Device
Activity by wearable device available data at 1 month, 6 months, 12 months, and 24 months over baseline.
Time frame: 1, 6, 12, and 24 months over baseline
Population: Data was not collected.
Secondary
Bilirubin [Full Analysis Data Set]
Bilirubin data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | Bilirubin [Full Analysis Data Set] | Bilirubin Baseline | 15.7 umol/L | Standard Deviation 17.5 |
| Cardioband Tricuspid Procedure | Bilirubin [Full Analysis Data Set] | Bilirubin 1 Month | 14.0 umol/L | Standard Deviation 13.4 |
| Cardioband Tricuspid Procedure | Bilirubin [Full Analysis Data Set] | Bilirubin 6 Months | 13.0 umol/L | Standard Deviation 5.8 |
| Cardioband Tricuspid Procedure | Bilirubin [Full Analysis Data Set] | Bilirubin 12 Months | 11.6 umol/L | Standard Deviation 7.9 |
| Cardioband Tricuspid Procedure | Bilirubin [Full Analysis Data Set] | Bilirubin 24 Months | 7.4 umol/L | Standard Deviation 6 |
Secondary
Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set]
All available data for Blood urea nitrogen (BUN) and Serum Creatinine at 1 month, 6 months, 12 months, and 24 months over baseline.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set] | Baseline | 52.8 mg/dL | Standard Deviation 30.3 |
| Cardioband Tricuspid Procedure | Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set] | 1 Month | 52.1 mg/dL | Standard Deviation 36 |
| Cardioband Tricuspid Procedure | Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set] | 6 Months | 64.2 mg/dL | Standard Deviation 55.1 |
| Cardioband Tricuspid Procedure | Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set] | 12 Months | 49.5 mg/dL | Standard Deviation 34.5 |
| Cardioband Tricuspid Procedure | Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set] | 24 Months | 50.5 mg/dL | Standard Deviation 55.7 |
Secondary
Diuretic Therapy
Diuretic Therapy data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Time frame: 1, 6, 12, and 24 months over baseline
Population: Data was not collected.
Secondary
Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set]
All data available for Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set] | Baseline | 0.8 cm^2 | Standard Deviation 0.5 |
| Cardioband Tricuspid Procedure | Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set] | 1 Month | 0.6 cm^2 | Standard Deviation 0.6 |
| Cardioband Tricuspid Procedure | Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set] | 6 Months | 0.4 cm^2 | Standard Deviation 0.3 |
| Cardioband Tricuspid Procedure | Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set] | 12 Months | 0.4 cm^2 | Standard Deviation 0.2 |
| Cardioband Tricuspid Procedure | Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set] | 24 Months | 0.3 cm^2 | Standard Deviation 0.2 |
Secondary
Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]
Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab
Time frame: 1, 6, 12, and 24 months over baseline
Population: The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline and 1 month, 6 months, 12 months, and 24 months is 28, 21, 18, and 12 respectively. The outcome is reported where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up] | Baseline (1 Month) | 0.8 cm^2 | Standard Deviation 0.5 |
| Cardioband Tricuspid Procedure | Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up] | 1 Month | 0.6 cm^2 | Standard Deviation 0.6 |
| Cardioband Tricuspid Procedure | Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up] | Baseline (6 Months) | 0.8 cm^2 | Standard Deviation 0.5 |
| Cardioband Tricuspid Procedure | Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up] | 6 Months | 0.4 cm^2 | Standard Deviation 0.3 |
| Cardioband Tricuspid Procedure | Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up] | Baseline (12 Months) | 0.8 cm^2 | Standard Deviation 0.5 |
| Cardioband Tricuspid Procedure | Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up] | 12 Months | 0.4 cm^2 | Standard Deviation 0.2 |
| Cardioband Tricuspid Procedure | Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up] | Baseline (24 Months) | 0.3 cm^2 | Standard Deviation 0.2 |
| Cardioband Tricuspid Procedure | Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up] | 24 Months | -0.6 cm^2 | Standard Deviation 0.4 |
Secondary
Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set]
All data available for Glutamic oxaloacetic transaminase (GOT) and Aspartate Transaminase (AST) at 1 month, 6 months, 12 months, and 24 months over baseline.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set] | Baseline | 28.3 U/L | Standard Deviation 9.5 |
| Cardioband Tricuspid Procedure | Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set] | 1 Month | 31.9 U/L | Standard Deviation 18.3 |
| Cardioband Tricuspid Procedure | Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set] | 6 Months | 30.9 U/L | Standard Deviation 21.3 |
| Cardioband Tricuspid Procedure | Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set] | 12 Months | 32.3 U/L | Standard Deviation 10.9 |
| Cardioband Tricuspid Procedure | Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set] | 24 Months | 27.6 U/L | Standard Deviation 9.6 |
Secondary
Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set]
All data available for glutamic pyruvic transaminase (GPT) Alanine Transaminase (ALT) at 1 month, 6 months, 12 months, and 24 months.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set] | Baseline | 21.9 IU/L | Standard Deviation 14 |
| Cardioband Tricuspid Procedure | Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set] | 1 Month | 25.1 IU/L | Standard Deviation 23.8 |
| Cardioband Tricuspid Procedure | Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set] | 6 Months | 23.4 IU/L | Standard Deviation 18.4 |
| Cardioband Tricuspid Procedure | Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set] | 12 Months | 24.6 IU/L | Standard Deviation 12.2 |
| Cardioband Tricuspid Procedure | Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set] | 24 Months | 18.6 IU/L | Standard Deviation 10.2 |
Secondary
Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set]
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set] | Baseline | 43.8 units on a scale | Standard Deviation 21.9 |
| Cardioband Tricuspid Procedure | Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set] | 1 Month | 56.7 units on a scale | Standard Deviation 24 |
| Cardioband Tricuspid Procedure | Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set] | 6 Months | 63.6 units on a scale | Standard Deviation 23.8 |
| Cardioband Tricuspid Procedure | Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set] | 12 Months | 59.6 units on a scale | Standard Deviation 22.7 |
| Cardioband Tricuspid Procedure | Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set] | 24 Months | 58.0 units on a scale | Standard Deviation 24.3 |
Secondary
Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline and 1 month, 6 months, 12 months, and 24 months is 37, 35, 31, and 28 respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up] | Baseline (1 Month) | 44.4 Score | Standard Deviation 21.8 |
| Cardioband Tricuspid Procedure | Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up] | 1 Month | 56.7 Score | Standard Deviation 24 |
| Cardioband Tricuspid Procedure | Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up] | Baseline (6 Months) | 44.6 Score | Standard Deviation 21.1 |
| Cardioband Tricuspid Procedure | Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up] | Baseline (12 Months) | 43.3 Score | Standard Deviation 21.6 |
| Cardioband Tricuspid Procedure | Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up] | 12 Months | 59.6 Score | Standard Deviation 22.7 |
| Cardioband Tricuspid Procedure | Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up] | Baseline (24 Months) | 47.0 Score | Standard Deviation 20.9 |
| Cardioband Tricuspid Procedure | Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up] | 24 Months | 58.0 Score | Standard Deviation 24.3 |
| Cardioband Tricuspid Procedure | Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up] | 6 Months | 63.6 Score | Standard Deviation 23.8 |
Secondary
Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set]
All available data for left ventricle ejection fraction at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per echo core lab.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set] | Baseline | 56.9 percent fraction | Standard Deviation 10.2 |
| Cardioband Tricuspid Procedure | Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set] | 1 Month | 57.0 percent fraction | Standard Deviation 8.3 |
| Cardioband Tricuspid Procedure | Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set] | 6 Months | 57.8 percent fraction | Standard Deviation 7.1 |
| Cardioband Tricuspid Procedure | Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set] | 12 Months | 59.0 percent fraction | Standard Deviation 6.3 |
| Cardioband Tricuspid Procedure | Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set] | 24 Months | 56.9 percent fraction | Standard Deviation 6.5 |
Secondary
Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]
Left ventricle ejection fraction data available for 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis based on core lab assessment.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline and 1 month, 6 months, 12 months, and 24 months is 31, 30, 25, and 19 respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up] | Baseline (1 Month) | 56.7 percent fraction | Standard Deviation 10 |
| Cardioband Tricuspid Procedure | Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up] | 1 Month | 57.0 percent fraction | Standard Deviation 8.4 |
| Cardioband Tricuspid Procedure | Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up] | Baseline (6 Months) | 56.2 percent fraction | Standard Deviation 10 |
| Cardioband Tricuspid Procedure | Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up] | 6 Months | 57.4 percent fraction | Standard Deviation 7.1 |
| Cardioband Tricuspid Procedure | Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up] | Baseline (12 Months) | 56.6 percent fraction | Standard Deviation 10.1 |
| Cardioband Tricuspid Procedure | Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up] | 12 Months | 58.8 percent fraction | Standard Deviation 6.5 |
| Cardioband Tricuspid Procedure | Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up] | Baseline (24 Months) | 57.8 percent fraction | Standard Deviation 8.8 |
| Cardioband Tricuspid Procedure | Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up] | 24 Months | 56.6 percent fraction | Standard Deviation 6.6 |
Secondary
Left Ventricle End Diastolic Volume Index (LVEDVI) [Full Analysis Data Set]
Left ventricle end diastolic volume index data available for 1 month, 6 months, 12 months, and 24 months over baseline.
Time frame: 1, 6, 12, and 24 months over baseline
Population: Data was not collected.
Secondary
Left Ventricle End Systolic Volume Index (LVESVI) [Full Analysis Data Set]
Left ventricle end systolic volume index data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Time frame: 1, 6, 12, and 24 months over baseline
Population: Data was not collected.
Secondary
NT-pro BNP [Full Analysis Data Set]
N-terminal prohormone of brain natriuretic peptide data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | NT-pro BNP [Full Analysis Data Set] | Baseline | 2899.3 ng/L | Standard Deviation 2632.5 |
| Cardioband Tricuspid Procedure | NT-pro BNP [Full Analysis Data Set] | 1 Month | 2874.5 ng/L | Standard Deviation 2860.5 |
| Cardioband Tricuspid Procedure | NT-pro BNP [Full Analysis Data Set] | 6 Months | 2563.1 ng/L | Standard Deviation 2510.2 |
| Cardioband Tricuspid Procedure | NT-pro BNP [Full Analysis Data Set] | 12 Months | 2095.5 ng/L | Standard Deviation 2306.4 |
| Cardioband Tricuspid Procedure | NT-pro BNP [Full Analysis Data Set] | 24 Months | 2119.1 ng/L | Standard Deviation 2461.3 |
Secondary
NYHA [Full Analysis Data Set]
All data available for NYHA classification at 1 month, 6 months, 12 months, and 24 months over baseline. Measure Description: NYHA Classification - The stages of heart failure: 1. Class I - No symptoms and no limitation in ordinary physical activity 2. Class II - Mild symptoms and slight limitation during ordinary activity. 3. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. 4. Class IV - Severe limitations. Experiences symptoms even while at rest.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 12 Months | IV | 1 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 24 Months | I | 6 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 12 Months | II | 12 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 12 Months | III | 7 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | Baseline | I | 0 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | Baseline | II | 6 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | Baseline | III | 32 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | Baseline | IV | 2 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 1 Month | I | 5 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 1 Month | II | 22 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 1 Month | III | 10 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 1 Month | IV | 0 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 6 Months | I | 8 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 6 Months | II | 19 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 6 Months | III | 8 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 6 Months | IV | 0 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 12 Months | I | 10 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 24 Months | II | 12 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 24 Months | III | 7 Participants |
| Cardioband Tricuspid Procedure | NYHA [Full Analysis Data Set] | 24 Months | IV | 0 Participants |
Secondary
NYHA [Paired Baseline and Follow-Up]
NYHA classification data available at 1 month, 6 months, 12 months, 24 months over baseline. Measure Description: NYHA Classification - The stages of heart failure: 1. Class I - No symptoms and no limitation in ordinary physical activity 2. Class II - Mild symptoms and slight limitation during ordinary activity. 3. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. 4. Class IV - Severe limitations. Experiences symptoms even while at rest.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline, 1 month, 6 months, 12 months, and 24 months is 37, 35, 30, and 25 respectively.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (1 Month) | I | 0 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (1 Month) | II | 6 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (1 Month) | III | 30 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (1 Month) | IV | 1 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 1 Month | I | 5 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 1 Month | II | 22 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 1 Month | III | 10 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 1 Month | IV | 0 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (6 Months) | I | 0 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (6 Months) | II | 6 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (6 Months) | III | 28 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (6 Months) | IV | 1 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 6 Months | I | 8 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 6 Months | III | 8 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 6 Months | IV | 0 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (12 Months) | I | 0 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (12 Months) | II | 6 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (12 Months) | III | 23 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (12 Months) | IV | 1 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 12 Months | I | 10 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 12 Months | II | 12 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 12 Months | III | 7 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 12 Months | IV | 1 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (24 Months) | I | 0 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (24 Months) | II | 5 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (24 Months) | III | 20 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | Baseline (24 Months) | IV | 0 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 24 Months | I | 6 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 24 Months | II | 12 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 24 Months | III | 7 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 24 Months | IV | 0 Participants |
| Cardioband Tricuspid Procedure | NYHA [Paired Baseline and Follow-Up] | 6 Months | II | 19 Participants |
Secondary
Regurgitant Volume [Full Analysis Data Set]
All data for Regurgitant Volume (by Echocardiography) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | Regurgitant Volume [Full Analysis Data Set] | Baseline | 104.4 ml | Standard Deviation 37 |
| Cardioband Tricuspid Procedure | Regurgitant Volume [Full Analysis Data Set] | 1 Month | 86.7 ml | Standard Deviation 51.7 |
| Cardioband Tricuspid Procedure | Regurgitant Volume [Full Analysis Data Set] | 6 Months | 78.4 ml | Standard Deviation 43.2 |
| Cardioband Tricuspid Procedure | Regurgitant Volume [Full Analysis Data Set] | 12 Months | 79.4 ml | Standard Deviation 35.4 |
| Cardioband Tricuspid Procedure | Regurgitant Volume [Full Analysis Data Set] | 24 Months | 56.7 ml | Standard Deviation 37.3 |
Secondary
Regurgitant Volume [Paired Baseline and Follow-Up]
Regurgitant Volume (by Echocardiography) data available at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline and 1 month, 6 months, 12 months, and 24 months is 11, 12, 3, and 4 respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | Regurgitant Volume [Paired Baseline and Follow-Up] | Baseline (1 Month) | 97.1 ml | Standard Deviation 35.6 |
| Cardioband Tricuspid Procedure | Regurgitant Volume [Paired Baseline and Follow-Up] | 1 Month | 70.7 ml | Standard Deviation 50.5 |
| Cardioband Tricuspid Procedure | Regurgitant Volume [Paired Baseline and Follow-Up] | Baseline (6 Months) | 104.2 ml | Standard Deviation 33.5 |
| Cardioband Tricuspid Procedure | Regurgitant Volume [Paired Baseline and Follow-Up] | 6 Months | 76.9 ml | Standard Deviation 51.5 |
| Cardioband Tricuspid Procedure | Regurgitant Volume [Paired Baseline and Follow-Up] | Baseline (12 Months) | 76.5 ml | Standard Deviation 32.2 |
| Cardioband Tricuspid Procedure | Regurgitant Volume [Paired Baseline and Follow-Up] | 12 Months | 51.2 ml | Standard Deviation 16.9 |
| Cardioband Tricuspid Procedure | Regurgitant Volume [Paired Baseline and Follow-Up] | Baseline (24 Months) | 98.1 ml | Standard Deviation 41.5 |
| Cardioband Tricuspid Procedure | Regurgitant Volume [Paired Baseline and Follow-Up] | 24 Months | 47.2 ml | Standard Deviation 35.3 |
Secondary
TAPSE [Full Analysis Data Set]
All data for Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analyses based on core lab assessment.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | TAPSE [Full Analysis Data Set] | Baseline | 1.5 cm | Standard Deviation 0.3 |
| Cardioband Tricuspid Procedure | TAPSE [Full Analysis Data Set] | 30 Days | 1.4 cm | Standard Deviation 0.4 |
| Cardioband Tricuspid Procedure | TAPSE [Full Analysis Data Set] | 6 Months | 1.4 cm | Standard Deviation 0.4 |
| Cardioband Tricuspid Procedure | TAPSE [Full Analysis Data Set] | 12 Months | 1.3 cm | Standard Deviation 0.3 |
| Cardioband Tricuspid Procedure | TAPSE [Full Analysis Data Set] | 24 Months | 1.4 cm | Standard Deviation 0.4 |
Secondary
TAPSE [Paired Baseline and Follow-Up]
Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline, 1 month, 6 months, 12 months, and 24 months is 28, 26, 24, and 17 respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | TAPSE [Paired Baseline and Follow-Up] | Baseline (30 Days) | 1.4 cm | Standard Deviation 0.4 |
| Cardioband Tricuspid Procedure | TAPSE [Paired Baseline and Follow-Up] | 30 Days | 1.3 cm | Standard Deviation 0.4 |
| Cardioband Tricuspid Procedure | TAPSE [Paired Baseline and Follow-Up] | Baseline (6 Months) | 1.4 cm | Standard Deviation 0.4 |
| Cardioband Tricuspid Procedure | TAPSE [Paired Baseline and Follow-Up] | 6 Months | 1.4 cm | Standard Deviation 0.3 |
| Cardioband Tricuspid Procedure | TAPSE [Paired Baseline and Follow-Up] | Baseline (12 Months) | 1.4 cm | Standard Deviation 0.3 |
| Cardioband Tricuspid Procedure | TAPSE [Paired Baseline and Follow-Up] | 12 Months | 1.3 cm | Standard Deviation 0.3 |
| Cardioband Tricuspid Procedure | TAPSE [Paired Baseline and Follow-Up] | Baseline (24 Months) | 1.4 cm | Standard Deviation 0.4 |
| Cardioband Tricuspid Procedure | TAPSE [Paired Baseline and Follow-Up] | 24 Months | 1.3 cm | Standard Deviation 0.4 |
Secondary
Technical Success
Successful access, deployment and positioning of the Cardioband device and septolateral reduction.
Time frame: 1, 6, 12, and 24 months
Population: Data was not collected
Secondary
Tricuspid Regurgitation [Full Analysis Data Set]
All data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, Severe. Data analysis per core lab.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The outcome is reported where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | Baseline | None | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | Baseline | Mild | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | Baseline | Moderate | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | Baseline | Severe | 40 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 1 Month | None | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 1 Month | Mild | 5 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 1 Month | Moderate | 11 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 1 Month | Severe | 21 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 6 Months | None | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 6 Months | Mild | 3 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 6 Months | Moderate | 10 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 6 Months | Severe | 20 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 12 Months | None | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 12 Months | Mild | 2 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 12 Months | Moderate | 9 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 12 Months | Severe | 16 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 24 Months | None | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 24 Months | Mild | 8 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 24 Months | Moderate | 7 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Full Analysis Data Set] | 24 Months | Severe | 5 Participants |
Secondary
Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, and Severe. Data analysis per core lab.
Time frame: 1, 6, 12, and 24 months over baseline
Population: The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline, 1 month, 30 days, 6 months, 12 months, and 24 months is 37, 33, 37, and 20 respectively. The outcome is reported where data is available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (6 Months) | Severe | 33 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (1 Month) | None | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (1 Month) | Mild | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (1 Month) | Moderate | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (1 Month) | Severe | 37 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 1 Month | None | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 1 Month | Mild | 5 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 1 Month | Moderate | 11 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 1 Month | Severe | 21 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (6 Months) | None | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (6 Months) | Mild | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (6 Months) | Moderate | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 6 Months | None | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 6 Months | Mild | 3 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 6 Months | Moderate | 10 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 6 Months | Severe | 20 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (12 Months) | None | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (12 Months) | Mild | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (12 Months) | Moderate | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (12 Months) | Severe | 27 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 12 Months | None | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 12 Months | Mild | 2 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 12 Months | Moderate | 9 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 12 Months | Severe | 16 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (24 Months) | None | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (24 Months) | Mild | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (24 Months) | Moderate | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | Baseline (24 Months) | Severe | 20 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 24 Months | None | 0 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 24 Months | Mild | 8 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 24 Months | Moderate | 7 Participants |
| Cardioband Tricuspid Procedure | Tricuspid Regurgitation [Paired Baseline and Follow-Up] | 24 Months | Severe | 5 Participants |