Clinical trial NCT02787408: The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System
Official title: The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tricuspid Valve Regurgitation
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2016-06-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Signed and dated Ethics Committee (EC) approved study consent form prior to study related procedures
2. Eighteen years of age or older
3. 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
4. Functional tricuspid regurgitation as the primary etiology
5. New York Heart Association (NYHA) Functional Class II or greater or signs of persistent right heart failure despite optimal medical therapy
6. 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
7. Willing to attend study follow-up assessments for up to 3 years

Exclusion Criteria

1. Tricuspid valve/right heart anatomy not suitable for the study device:

   1. 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
   2. Sub-valvular structures/anatomy that would preclude from proper anchor or coaptation device placement, positioning and retrieval
   3. Access pathway vessel diameter less than 7.1 mm (9, 12 mm and 15 mm devices)
2. Moderate or greater tricuspid valve stenosis
3. Untreated clinically significant coronary artery disease requiring immediate revascularization
4. Any therapeutic invasive cardiac procedure performed within 30 days of the scheduled implant procedure
5. Patients not already receiving dialysis with renal insufficiency (eGFR \<25) per lab test ≤ 48 hours prior to scheduled implant procedure
6. Myocardial infarction within 30 days of scheduled implant procedure
7. Hemodynamic instability within 30 days of scheduled implant procedure
8. Patient requiring surgery under general anesthesia for any reason within 90 days of scheduled implant procedure
9. Severe left ventricular dysfunction with ejection fraction \< 25% within 90 days of scheduled implant procedure
10. Patients with pulmonary artery systolic pressure \> 70 mmHg via transthoracic echocardiography or alternative standard modality (e.g., direct pressure measurement) within 90 days
11. Concomitant clinically significant valve (aortic, mitral, or pulmonic) disease requiring immediate (± 30 days of study procedure) repair or replacement
12. Active endocarditis or infection within 3 months of scheduled implant procedure
13. Cerebrovascular accident within 3 months of scheduled implant procedure
14. Non-cardiac disease limiting life expectancy to be less than 12 months at baseline evaluation
15. Documented history of bleeding diathesis, coagulopathy or gastrointestinal bleeding within 3 months of scheduled implant procedure
16. Evidence of right sided intracardiac mass, thrombus, or vegetation
17. Prior venous stent placed within the access route (e.g., sub-clavian vein) that could negatively react with device
18. Previously treated tricuspid valve which included implantation of a bioprosthetic valve or mechanical valve
19. Known hypersensitivity to cobalt chromium, nitinol or titanium
20. Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated
21. Patient is a current intravenous drug user
22. Female of child-bearing potential is pregnant or lactating
23. Patient is currently participating or has participated in another investigational drug or device clinical study within 30 days of study screening activity
24. Patient requires emergent/emergency treatment for tricuspid insufficiency
25. Patient is under guardianship

Primary outcomes:
measure: All-cause Mortality
timeFrame: At 30 days.
Secondary outcomes:
measure: Technical Success
timeFrame: Implant Procedure
measure: Device Success
timeFrame: At 1 month, 6 months, 1, 2, and 3 years
measure: Procedural Success
timeFrame: At 1 month
measure: Clinical Outcomes [Heart Failure Re-Hospitalization Rates]
timeFrame: At 1 month, 6 months, 1, 2 and 3 years
measure: Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates]
timeFrame: At 1 month, 6 months, 1, 2 and 3 years
measure: Clinical Outcomes [Changes in Peripheral Edema]
timeFrame: At 1 month, 6 months, 1, 2 and 3 years
measure: Clinical Outcomes [Change in New York Heart Association (NYHA) Class]
timeFrame: At 1 month, 6 months, 1, 2 and 3 years
measure: Clinical Outcomes [Change in 6 Minute Walk Test Distance]
timeFrame: At 1 month, 6 months, 1, 2 and 3 years
measure: Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]
timeFrame: At 1 month, 6 months, 1, 2 and 3 years
measure: Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]
timeFrame: At 1 month, 6 months, 1, 2 and 3 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital, Providence Health Care Research Institute
state: British Columbia
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite Laval
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Rouen
country: France
facility: Hōpital Charles Nicolle
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen
city: Berlin
country: Germany
facility: Charite-Universitätsmedzin Berlin
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Munich
country: Germany
facility: Munich University Clinic, Ludwig-Maximilian University
city: Athens
country: Greece
facility: Hygeia Hospital
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern
Study officials:
References: