The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tricuspid Valve Regurgitation
- Sponsor
- Edwards Lifesciences
- Enrollment
- 25
- Locations
- 11
- Primary Endpoint
- All-cause Mortality
- Status
- Completed
- Last Updated
- 3 years ago
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.
Investigators
Eligibility 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
Exclusion Criteria
- Not provided
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)