The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System (SPACER)

• Sponsor: Edwards Lifesciences
• Information provided by (Responsible Party): Edwards Lifesciences

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
Tricuspid Valve Regurgitation	Device: EW Tricuspid Transcatheter Repair System	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 78 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System
• Study Start Date: September 2016
• Estimated Primary Completion Date: March 2018
• Estimated Study Completion Date: December 2020

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 :

1. 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. [ Time Frame: The primary endpoint will be assessed at 30 days. ]

Secondary Outcome Measures :

1. Technical Success [ Time Frame: 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
2. Device Success [ Time Frame: At 1 month ]

   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
3. Procedural Success [ Time Frame: At 1 month ]

   Device Success, and

   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
4. Clinical Outcomes [Heart Failure Re-Hospitalization Rates] (1 of 7) [ Time Frame: At 1 month, 6 months, 1 year, 2 years, and 3 years ]
   Re-hospitalization rates for the underlying condition (heart failure)
5. Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates] (2 of 7) [ Time Frame: At 1 month, 6 months, 1 year, 2 years, and 3 years ]
   Re-intervention rates for the underlying condition (tricuspid regurgitation)
6. Clinical Outcomes [Changes in Peripheral Edema] (3 of 7) [ Time Frame: At 1 month, 6 months, 1 year, 2 years, and 3 years ]
   Change in peripheral edema as assessed by subject weight loss (kilograms) from baseline
7. Clinical Outcomes [Change in New York Heart Association (NYHA) Class] (4 of 7) [ Time Frame: At 1 month, 6 months, 1 year, 2 years, and 3 years ]
   Change in New York Heart Association (NYHA) Class from baseline
8. Clinical Outcomes [Change in 6 Minute Walk Test Distance] (5 of 7) [ Time Frame: At 1 month, 6 months, 1 year, 2 years, and 3 years ]
   Change in 6 minute walk test distance (meters) from baseline
9. Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire] (6 of 7) [ Time Frame: At 1 month, 6 months, 1 year, 2 years, and 3 years ]
   Change in Quality of Life as assessed by the Short Form (SF)-12 questionnaire from baseline
10. Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)] (7 of 7) [ Time Frame: At 1 month, 6 months, 1 year, 2 years, and 3 years ]
    Change in Quality of Life as assessed by the KCCQ questionnaire from baseline

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, British Columbia

St. Paul's Hospital, Providence Health Care Research Institute

Vancouver, British Columbia, Canada, V6E 1M7

Canada, Ontario

Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

Canada

Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite Laval

Quebec, Canada, G1V 4G5

France

Institut Hospitalier Jacques Cartier

Massy, France, 91300

Hōpital Charles Nicolle

Rouen, France, 76031

Clinique Pasteur

Toulouse, France, 31076

Germany

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Germany, 79189

Charite-Universitätsmedzin Berlin

Berlin, Germany, 10117

Asklepios Klinik St. Georg

Hamburg, Germany, 20099

Munich University Clinic, Ludwig-Maximilian University

Munich, Germany, 81377

Greece

Hygeia Hospital

Athens, Greece, 15123

Switzerland

Inselspital, Universitätsspital Bern

Bern, Switzerland, 3010

Sponsors and Collaborators

Edwards Lifesciences

More Information

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT02787408 History of Changes
• Other Study ID Numbers: 2015-09
• First Posted: June 1, 2016
• Last Update Posted: December 26, 2017
• Last Verified: September 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Tricuspid Valve Insufficiency; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases