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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Tricuspid Valve Regurgitation

Intervention / Treatment
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* Device: EW Tricuspid Transcatheter Repair System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated Ethics Committee (EC) approved study consent form prior to study related procedures Eighteen years of age or older 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 Functional tricuspid regurgitation as the primary etiology New York Heart Association (NYHA) Functional Class II or greater or signs of persistent right heart failure despite optimal medical therapy 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 Willing to attend study follow-up assessments for up to 3 years Exclusion Criteria Tricuspid valve/right heart anatomy not suitable for the study device: 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 Sub-valvular structures/anatomy that would preclude from proper anchor or coaptation device placement, positioning and retrieval Access pathway vessel diameter less than 7.1 mm (9, 12 mm and 15 mm devices) Moderate or greater tricuspid valve stenosis Untreated clinically significant coronary artery disease requiring immediate revascularization Any therapeutic invasive cardiac procedure performed within 30 days of the scheduled implant procedure Patients not already receiving dialysis with renal insufficiency (eGFR <25) per lab test ≤ 48 hours prior to scheduled implant procedure Myocardial infarction within 30 days of scheduled implant procedure Hemodynamic instability within 30 days of scheduled implant procedure Patient requiring surgery under general anesthesia for any reason within 90 days of scheduled implant procedure Severe left ventricular dysfunction with ejection fraction < 25% within 90 days of scheduled implant procedure Patients with pulmonary artery systolic pressure > 70 mmHg via transthoracic echocardiography or alternative standard modality (e.g., direct pressure measurement) within 90 days Concomitant clinically significant valve (aortic, mitral, or pulmonic) disease requiring immediate (± 30 days of study procedure) repair or replacement Active endocarditis or infection within 3 months of scheduled implant procedure Cerebrovascular accident within 3 months of scheduled implant procedure Non-cardiac disease limiting life expectancy to be less than 12 months at baseline evaluation Documented history of bleeding diathesis, coagulopathy or gastrointestinal bleeding within 3 months of scheduled implant procedure Evidence of right sided intracardiac mass, thrombus, or vegetation Prior venous stent placed within the access route (e.g., sub-clavian vein) that could negatively react with device Previously treated tricuspid valve which included implantation of a bioprosthetic valve or mechanical valve Known hypersensitivity to cobalt chromium, nitinol or titanium Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated Patient is a current intravenous drug user Female of child-bearing potential is pregnant or lactating Patient is currently participating or has participated in another investigational drug or device clinical study within 30 days of study screening activity Patient requires emergent/emergency treatment for tricuspid insufficiency Patient is under guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EW Tricuspid Transcatheter Repair System<br>Edwards (EW) Tricuspid Transcatheter Repair System | Device: EW Tricuspid Transcatheter Repair System<br>* Treatment with the EW Tricuspid Transcatheter Repair System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 30 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | 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 | Implant Procedure | 
| Device Success | 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 | At 1 month, 6 months, 1, 2, and 3 years | 
| Procedural Success | 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 | At 1 month | 
| Clinical Outcomes [Heart Failure Re-Hospitalization Rates] | Re-hospitalization rates for the underlying condition (heart failure) | At 1 month, 6 months, 1, 2 and 3 years | 
| Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates] | Re-intervention rates for the underlying condition (tricuspid regurgitation) | At 1 month, 6 months, 1, 2 and 3 years | 
| Clinical Outcomes [Changes in Peripheral Edema] | Change in peripheral edema as assessed by subject weight loss (kilograms) compared to baseline | At 1 month, 6 months, 1, 2 and 3 years | 
| Clinical Outcomes [Change in New York Heart Association (NYHA) Class] | 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. | At 1 month, 6 months, 1, 2 and 3 years | 
| Clinical Outcomes [Change in 6 Minute Walk Test Distance] | Change in 6 minute walk test distance (meters) compared to baseline | At 1 month, 6 months, 1, 2 and 3 years | 
| Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire] | 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. | At 1 month, 6 months, 1, 2 and 3 years | 
| Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)] | 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. | At 1 month, 6 months, 1, 2 and 3 years |