N/A
N=25
The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System
Tricuspid Valve Regurgitation
Bottom Line
View on ClinicalTrials.gov: NCT02787408 ↗Enrolled (actual)
25
Serious AEs
80.0%
Results posted
Oct 2022
Primary outcome: Primary: All-cause Mortality — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EW Tricuspid Transcatheter Repair System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality |
2 | — |
| SECONDARY Technical Success |
22 | — |
| SECONDARY Device Success |
4; 3; 3; 2; 0 | — |
| SECONDARY Procedural Success |
4 | — |
| SECONDARY Clinical Outcomes [Heart Failure Re-Hospitalization Rates] |
100.0; 91.3; 85.6; 72.9; 72.9 | — |
| SECONDARY Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates] |
96.0; 96.0; 96.0; 96.0; 96.0 | — |
| SECONDARY Clinical Outcomes [Changes in Peripheral Edema] |
75.1; 73.1; 72.7; 70.2; 74.3; 71.0 | — |
| SECONDARY Clinical Outcomes [Change in New York Heart Association (NYHA) Class] |
0; 5; 12; 5; 2; 12 | — |
| SECONDARY Clinical Outcomes [Change in 6 Minute Walk Test Distance] |
328.7; 333.2; 329.9; 351.6; 320.9; 353.0 | — |
| SECONDARY Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire] |
36.3; 39.4; 37.7; 40.3; 35.6; 42.7 | — |
| SECONDARY Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)] |
48.7; 59.6; 49.7; 71.9; 46.2; 70.8 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT02787408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.