The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02787408

Acronym

SPACER

Enrollment

Registered

2016-06-01

Start date

2016-09-14

Completion date

2020-12-14

Last updated

2022-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid Valve Regurgitation

Brief summary

Detailed description

The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement. The study is a multi-center, international, prospective, single arm, safety study. Enrolled subjects will be assessed for clinical follow-up at 1 month, 6 months, 1 year and annually for 3 years post implant procedure.

Interventions

DEVICEEW Tricuspid Transcatheter Repair System

Treatment with the EW Tricuspid Transcatheter Repair System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Signed and dated Ethics Committee (EC) approved study consent form prior to study related procedures 2. Eighteen years of age or older 3. Clinically significant, symptomatic (New York Heart Association (NYHA) Functional Class II or greater), tricuspid regurgitation (per applicable guidelines) requiring tricuspid valve repair or replacement as assessed by the Heart Team 4. Functional tricuspid regurgitation as the primary etiology 5. New York Heart Association (NYHA) Functional Class II or greater or signs of persistent right heart failure despite optimal medical therapy 6. Determined by the 'HEART Team' (a minimum of one Cardiologist, and one Cardiac Surgeon) to be at high surgical risk for tricuspid valve repair or replacement and the benefit-risk analysis supports utilization of the investigational device 7. Willing to attend study follow-up assessments for up to 3 years

Exclusion criteria

1. Tricuspid valve/right heart anatomy not suitable for the study device: 1. Native tricuspid annulus area \< 2.14 cm2 (9 mm device) or \< 2.63 cm2 (12 mm device) or \< 3.27cm2 (15 mm device) as measured by transthoracic echocardiography 2. Sub-valvular structures/anatomy that would preclude from proper anchor or coaptation device placement, positioning and retrieval 3. Access pathway vessel diameter less than 7.1 mm (9, 12 mm and 15 mm devices) 2. Moderate or greater tricuspid valve stenosis 3. Untreated clinically significant coronary artery disease requiring immediate revascularization 4. Any therapeutic invasive cardiac procedure performed within 30 days of the scheduled implant procedure 5. Patients not already receiving dialysis with renal insufficiency (eGFR \<25) per lab test ≤ 48 hours prior to scheduled implant procedure 6. Myocardial infarction within 30 days of scheduled implant procedure 7. Hemodynamic instability within 30 days of scheduled implant procedure 8. Patient requiring surgery under general anesthesia for any reason within 90 days of scheduled implant procedure 9. Severe left ventricular dysfunction with ejection fraction \< 25% within 90 days of scheduled implant procedure 10. Patients with pulmonary artery systolic pressure \> 70 mmHg via transthoracic echocardiography or alternative standard modality (e.g., direct pressure measurement) within 90 days 11. Concomitant clinically significant valve (aortic, mitral, or pulmonic) disease requiring immediate (± 30 days of study procedure) repair or replacement 12. Active endocarditis or infection within 3 months of scheduled implant procedure 13. Cerebrovascular accident within 3 months of scheduled implant procedure 14. Non-cardiac disease limiting life expectancy to be less than 12 months at baseline evaluation 15. Documented history of bleeding diathesis, coagulopathy or gastrointestinal bleeding within 3 months of scheduled implant procedure 16. Evidence of right sided intracardiac mass, thrombus, or vegetation 17. Prior venous stent placed within the access route (e.g., sub-clavian vein) that could negatively react with device 18. Previously treated tricuspid valve which included implantation of a bioprosthetic valve or mechanical valve 19. Known hypersensitivity to cobalt chromium, nitinol or titanium 20. Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated 21. Patient is a current intravenous drug user 22. Female of child-bearing potential is pregnant or lactating 23. Patient is currently participating or has participated in another investigational drug or device clinical study within 30 days of study screening activity 24. Patient requires emergent/emergency treatment for tricuspid insufficiency 25. Patient is under guardianship

Design outcomes

Primary

Measure	Time frame	Description
All-cause Mortality	At 30 days.	The primary endpoint for the study will assess the all-cause mortality of the as treated cohort at 30 days compared to a literature derived Performance Goal based on high-risk surgical outcomes for tricuspid repair/replacement. Due to the early termination of the study, the desired statistical power was not attained and thus this comparison analysis was not performed. All-cause mortality is presented below as a number of deaths and percentage of patients only.

Secondary

Measure	Time frame	Description
Device Success	At 1 month, 6 months, 1, 2, and 3 years	Alive, with * Original intended device in place, and * No additional surgical or interventional procedures related to the device, and * Tricuspid Regurgitation (TR) reduction compared to baseline and Tricuspid Valve (TV) gradient ≤ 5 mmHg
Procedural Success	At 1 month	Device Success, and None of the following device or procedure related Serious Adverse Events (SAE): * Life threatening bleeding * Major vascular or cardiac structural complications requiring intervention * Pericardial effusion requiring drainage or surgery (includes tamponade) * Stage 2 or 3 acute kidney injury (includes new dialysis). * Severe heart failure or hypotension requiring Intravenous (IV) inotrope, ultrafiltration or mechanical circulatory support * Prolonged intubation \> 48 hours
Clinical Outcomes [Heart Failure Re-Hospitalization Rates]	At 1 month, 6 months, 1, 2 and 3 years	Re-hospitalization rates for the underlying condition (heart failure)
Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates]	At 1 month, 6 months, 1, 2 and 3 years	Re-intervention rates for the underlying condition (tricuspid regurgitation)
Technical Success	Implant Procedure	Alive, with * Successful access, delivery and removal of the delivery systems, and * Deployment and correct positioning of the intended device, and * No need for additional emergency surgery or re-intervention related to the device or access procedure
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]	At 1 month, 6 months, 1, 2 and 3 years	Change in New York Heart Association (NYHA) Class compared to baseline Measure Description: Measure Description: NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.
Clinical Outcomes [Change in 6 Minute Walk Test Distance]	At 1 month, 6 months, 1, 2 and 3 years	Change in 6 minute walk test distance (meters) compared to baseline
Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]	At 1 month, 6 months, 1, 2 and 3 years	Change in Quality of Life as assessed by the Short Form (SF)-12 questionnaire compared to baseline The SF-12 is a short survey with 12 questions that results in two scales of mental and physical functioning and overall health related quality of life. The SF-12 Score is scaled from 0-100, with higher scores indicating better physical and mental health functioning.
Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]	At 1 month, 6 months, 1, 2 and 3 years	Change in Quality of Life as assessed by the KCCQ questionnaire compared to baseline The KCCQ is a 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. The KCCQ scale is 0-100. 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.
Clinical Outcomes [Changes in Peripheral Edema]	At 1 month, 6 months, 1, 2 and 3 years	Change in peripheral edema as assessed by subject weight loss (kilograms) compared to baseline

Countries

Canada, France, Germany, Greece, Switzerland

Participant flow

Participants by arm

Arm	Count
EW Tricuspid Transcatheter Repair System Edwards (EW) Tricuspid Transcatheter Repair System EW Tricuspid Transcatheter Repair System: Treatment with the EW Tricuspid Transcatheter Repair System	25
Total	25

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	16
Overall Study	Non-implanted patient exited post 6 month follow-up visit per protocol	1
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	EW Tricuspid Transcatheter Repair System	—
Age, Continuous	74.6 years STANDARD_DEVIATION 7.06	—
Body Mass Index (BMI)	26.2 kg/m^2 STANDARD_DEVIATION 4.74	—
Cancer	3 Participants	—
Carotid Artery Disease	2 Participants	—
Coagulopathy	0 Participants	—
Coronary Artery Disease	10 Participants	—
Diabetes No	22 Participants	—
Diabetes Type 1	0 Participants	—
Diabetes Type II ( Insulin treated)	1 Participants	—
Diabetes Type II ( Non-Insulin treated)	2 Participants	—
History of Heart Failure	13 Participants	—
Hospitalization for Heart Failure prior 6 months	13 Participants	—
Hyperlipidemia	8 Participants	—
Hypertension	14 Participants	—
Liver Disease	3 Participants	—
Myocardial Infarction (MI)	0 Participants	—
New York Heart Association Class (NYHA) Class I	0 Participants	—
New York Heart Association Class (NYHA) Class II	6 Participants	—
New York Heart Association Class (NYHA) Class III	14 Participants	—
New York Heart Association Class (NYHA) Class IV	5 Participants	—
Pacemaker/Implantable cardioverter-defibrillator (ICD)	4 Participants	—
Peripheral Vascular Disease	3 Participants	—
Prior Coronary Artery Bypass Graft (CABG)	5 Participants	—
Prior Percutaneous Coronary Intervention (PCI)	5 Participants	—
Prior valve implant	13 Participants	—
Pulmonary Disease	2 Participants	—
Pulmonary Hypertension	12 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Canada	11 Participants	—
Region of Enrollment France	1 Participants	—
Region of Enrollment Germany	8 Participants	—
Region of Enrollment Greece	4 Participants	—
Region of Enrollment Switzerland	1 Participants	—
Sex: Female, Male Female	11 Participants	—
Sex: Female, Male Male	14 Participants	—
Stroke	5 Participants	—
The European System for Cardiac Operative Risk Evaluation: EuroScore II	11.5 Percentage of surgical risk STANDARD_DEVIATION 7.65	—
Transient Ischemic Attack (TIA)	0 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	16 / 25
other Total, other adverse events	23 / 25
serious Total, serious adverse events	20 / 25

Outcome results

Primary

All-cause Mortality

The primary endpoint for the study will assess the all-cause mortality of the as treated cohort at 30 days compared to a literature derived Performance Goal based on high-risk surgical outcomes for tricuspid repair/replacement. Due to the early termination of the study, the desired statistical power was not attained and thus this comparison analysis was not performed. All-cause mortality is presented below as a number of deaths and percentage of patients only.

Time frame: At 30 days.

Population: As Treated (AT) Cohort: All subjects who are enrolled and undergo the study procedure (chest incision)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
EW Tricuspid Transcatheter Repair System	All-cause Mortality	2 Participants

Secondary