The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EW Tricuspid Transcatheter Repair System Edwards (EW) Tricuspid Transcatheter Repair System |
Device: EW Tricuspid Transcatheter Repair System
Treatment with the EW Tricuspid Transcatheter Repair System
|
Outcome Measures
Primary Outcome Measures
- Mortality [At 30 days.]
The primary endpoint for the study will assess the mortality (cardiac) 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.
Secondary Outcome Measures
- 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
- 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 Device Success, and [At 1 month]
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)
- 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) from baseline
- 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 from baseline
- 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) from 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 from baseline
- 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 from baseline
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Paul's Hospital, Providence Health Care Research Institute | Vancouver | British Columbia | Canada | V6E 1M7 |
| 2 | Toronto General Hospital | Toronto | Ontario | Canada | M5G 2C4 |
| 3 | Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite Laval | Quebec | Canada | G1V 4G5 | |
| 4 | Institut Hospitalier Jacques Cartier | Massy | France | 91300 | |
| 5 | Hōpital Charles Nicolle | Rouen | France | 76031 | |
| 6 | Universitäts-Herzzentrum Freiburg - Bad Krozingen | Bad Krozingen | Germany | 79189 | |
| 7 | Charite-Universitätsmedzin Berlin | Berlin | Germany | 10117 | |
| 8 | Asklepios Klinik St. Georg | Hamburg | Germany | 20099 | |
| 9 | Munich University Clinic, Ludwig-Maximilian University | Munich | Germany | 81377 | |
| 10 | Hygeia Hospital | Athens | Greece | 15123 | |
| 11 | Inselspital, Universitätsspital Bern | Bern | Switzerland | 3010 |
Sponsors and Collaborators
- Edwards Lifesciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015-09