NCT02787408CompletedNot Applicable
The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System
Edwards Lifesciences22 sites in 5 countries25 target enrollmentStarted: September 14, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 22
- Primary Endpoint
- All-cause Mortality
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
All-cause Mortality
Time Frame: 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 Outcomes
- Technical Success(Implant Procedure)
- Device Success(At 1 month, 6 months, 1, 2, and 3 years)
- Procedural Success(At 1 month)
- Clinical Outcomes [Heart Failure Re-Hospitalization Rates](At 1 month, 6 months, 1, 2 and 3 years)
- Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates](At 1 month, 6 months, 1, 2 and 3 years)
- Clinical Outcomes [Changes in Peripheral Edema](At 1 month, 6 months, 1, 2 and 3 years)
- Clinical Outcomes [Change in New York Heart Association (NYHA) Class](At 1 month, 6 months, 1, 2 and 3 years)
- Clinical Outcomes [Change in 6 Minute Walk Test Distance](At 1 month, 6 months, 1, 2 and 3 years)
- Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire](At 1 month, 6 months, 1, 2 and 3 years)
- Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)](At 1 month, 6 months, 1, 2 and 3 years)
Investigators
Study Sites (22)
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