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

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.

Study Overview

• Status: Completed
• Conditions: Tricuspid Valve Regurgitation
• Intervention / Treatment: Device: EW Tricuspid Transcatheter Repair System

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval
  • British Columbia
    • Vancouver, British Columbia, Canada, V6E 1M7
      • St. Paul's Hospital, Providence Health Care Research Institute
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
• France
  • Massy, France, 91300
    • Institut Hospitalier Jacques Cartier
  • Rouen, France, 76031
    • Hopital Charles Nicolle
• Germany
  • Bad Krozingen, Germany, 79189
    • Universitäts-Herzzentrum Freiburg - Bad Krozingen
  • Berlin, Germany, 10117
    • Charite-Universitätsmedzin Berlin
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Munich, Germany, 81377
    • Munich University Clinic, Ludwig-Maximilian University
• Greece
  • Athens, Greece, 15123
    • Hygeia Hospital
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Universitätsspital Bern

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Mortality	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.	At 30 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	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	Implant Procedure
Device Success	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	At 1 month, 6 months, 1, 2, and 3 years
Procedural Success	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	At 1 month
Clinical Outcomes [Heart Failure Re-Hospitalization Rates]	Re-hospitalization rates for the underlying condition (heart failure)	At 1 month, 6 months, 1, 2 and 3 years
Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates]	Re-intervention rates for the underlying condition (tricuspid regurgitation)	At 1 month, 6 months, 1, 2 and 3 years
Clinical Outcomes [Changes in Peripheral Edema]	Change in peripheral edema as assessed by subject weight loss (kilograms) compared to baseline	At 1 month, 6 months, 1, 2 and 3 years
Clinical Outcomes [Change in New York Heart Association (NYHA) Class]	Change in New York Heart Association (NYHA) Class compared to baseline Measure Description: Measure Description: NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.	At 1 month, 6 months, 1, 2 and 3 years
Clinical Outcomes [Change in 6 Minute Walk Test Distance]	Change in 6 minute walk test distance (meters) compared to baseline	At 1 month, 6 months, 1, 2 and 3 years
Clinical Outcomes [Change in Quality of Life Short Form (SF)-12 Questionnaire]	Change in Quality of Life as assessed by the Short Form (SF)-12 questionnaire compared to baseline The SF-12 is a short survey with 12 questions that results in two scales of mental and physical functioning and overall health related quality of life. The SF-12 Score is scaled from 0-100, with higher scores indicating better physical and mental health functioning.	At 1 month, 6 months, 1, 2 and 3 years
Clinical Outcomes [Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)]	Change in Quality of Life as assessed by the KCCQ questionnaire compared to baseline The KCCQ is a 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. The KCCQ scale is 0-100. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.	At 1 month, 6 months, 1, 2 and 3 years

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2016
• Primary Completion (Actual): January 30, 2018
• Study Completion (Actual): December 14, 2020

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 2015-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No