Tricuspid Valve Insufficiency
Conditions
Keywords
TRILUMINATE, Percutaneous transcatheter intervention, Tricuspid regurgitation, Tricuspid Valve Repair System
Brief summary
The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention.
Detailed description
This is a prospective, single arm, multi-center study. A minimum of 85 subjects will be prospectively enrolled into this single arm study in approximately 25 sites, in Europe, Canada and the United States. Patients will be seen for follow-up visits at discharge (≤ 7 days post index procedure), 30 days, 6 months, 1,2,3 years.
Interventions
DEVICETricuspid Valve Repair System
Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Subject must be ≥18 years and ≤ 90 years at time of consent and must not be a member of a vulnerable population. 2. Subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure. 3. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure. 4. In the judgment of the investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, mitral regurgitation and heart failure at least 30-days prior to index procedure. The Eligibility Committee must concur that the subject has been adequately treated. 5. New York Heart Association (NYHA) Functional Class II (conditional), III, or ambulatory IV 1. Subjects with moderate TR: Only NYHA Class III or IV may be considered 2. Subjects with severe or greater TR: NYHA II, III, or IV may be considered for inclusion 6. No indication for left-sided or pulmonary valve correction. 7. The Site Heart Team concur the benefit-risk analysis supports intervention for tricuspid regurgitation per current guidelines for the management of Valvular heart disease and that the subject is at high risk for tricuspid valve surgery. 8. In the judgement of the TVRS implanting investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter. Echocardiographic Inclusion Criteria: 9. Moderate or greater (≥2+) Tricuspid Regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE) confirmed by the Echocardiography Core Lab (ECL). 10. Tricuspid valve anatomy determined to be suitable for implantation determined by the site heart team. 11. Tricuspid valve anatomy evaluable by TTE and TEE.
Exclusion criteria
1. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. 2. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test. 3. Severe uncontrolled hypertension (Systolic blood pressure \[SBP\] ≥ 180 mmHg and/or Diastolic blood pressure \[DBP\] ≥ 110 mm Hg). 4. Systolic Pulmonary Artery Pressure \> 60 mmHg (echo determined). 5. Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure. 6. Mitral Regurgitation moderate-severe or greater severity (≥3+). 7. Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of TVRS Clip. 8. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease. 9. Myocardial Infarction (MI) or known unstable angina within prior 30 days prior to enrollment. 10. Percutaneous coronary intervention within prior 30 days prior to enrollment. 11. Hemodynamic instability defined as systolic pressure \< 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device. 12. Cerebrovascular Accident (CVA) within prior 3 months to enrollment. 13. Chronic dialysis. 14. Bleeding disorders or hypercoagulable state. 15. Active peptic ulcer or active gastrointestinal (GI) bleeding. 16. Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant therapy. 17. Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 4 weeks after discontinuation of antibiotics with no active infection). 18. Known allergy or hypersensitivity to device materials. 19. In the judgement of the investigator, a condition that could limit a patient's ability or unwillingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study. 20. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation. 21. Life expectancy of less than 12 months due to non-cardiac conditions. Echocardiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade | At 30 days | Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR. |
| Number of Participants With Composite of Major Adverse Event (MAE) | At 6 months | Major Adverse Event (MAE) is defined as a composite of: * Cardiovascular Mortality * Myocardial Infarction (MI) * Stroke * New onset renal failure * Endocarditis requiring surgery, and * Non-elective cardio-vascular (CV) surgery for TVRS device-related AE post-procedure |
Countries
France, Germany, Italy, Spain, Switzerland, United States
Participant flow
Recruitment details
A total of 98 subjects were enrolled and underwent Tricuspid Valve Repair System (TVRS) procedure.
Participants by arm
| Arm | Count |
|---|---|
| Tricuspid Valve Repair System Subjects who received TVRS will be included in this arm.
Tricuspid Valve Repair System: Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation. | 98 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 25 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Missed visits | 1 |
| Overall Study | Withdrawal | 10 |
Baseline characteristics
| Characteristic | Tricuspid Valve Repair System |
|---|---|
| Age, Continuous | 77.5 years STANDARD_DEVIATION 8.1 |
| New York Heart Association (NYHA) class II or above NYHA class I | 0 Participants |
| New York Heart Association (NYHA) class II or above NYHA class II | 23 Participants |
| New York Heart Association (NYHA) class II or above NYHA class III | 69 Participants |
| New York Heart Association (NYHA) class II or above NYHA class IV | 4 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 6 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown or Not Reported | 65 Participants |
| Region of Enrollment France | 2 Participants |
| Region of Enrollment Germany | 45 Participants |
| Region of Enrollment Italy | 11 Participants |
| Region of Enrollment Spain | 8 Participants |
| Region of Enrollment Switzerland | 7 Participants |
| Region of Enrollment United States | 25 Participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 25 / 98 |
| other Total, other adverse events | 88 / 98 |
| serious Total, serious adverse events | 68 / 98 |
Outcome results
Primary
Number of Participants With Composite of Major Adverse Event (MAE)
Major Adverse Event (MAE) is defined as a composite of: * Cardiovascular Mortality * Myocardial Infarction (MI) * Stroke * New onset renal failure * Endocarditis requiring surgery, and * Non-elective cardio-vascular (CV) surgery for TVRS device-related AE post-procedure
Time frame: At 6 months
Population: The first 85 enrolled subjects with an attempted TriClip™ procedure upon femoral vein puncture. Note: The sample size and power estimation specified in the clinical investigation protocol indicated that a total of 85 subjects provided sufficient power to evaluate the primary endpoints. One subject withdrew from the study prior to the early window of the 6-month visit, without any reported adverse events, and was therefore excluded from the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tricuspid Valve Repair System | Number of Participants With Composite of Major Adverse Event (MAE) | 5 Participants |
Primary
Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR.
Time frame: At 30 days
Population: The first 85 enrolled subjects with an attempted TriClip™ procedure upon femoral vein puncture. Note: The sample size and power estimation specified in the clinical investigation protocol indicated that a total of 85 subjects provided sufficient power to evaluate the primary endpoints. This endpoint was assessed in 82 of the 85 subjects. The reason for the inability to assess the endpoint in 3 subjects was missing echocardiogram data and limited imaging quality at baseline (1) and 30 days (2).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tricuspid Valve Repair System | Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade | 71 Participants |