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

Not Applicable

Completed

Conditions: Tricuspid Valve Regurgitation

Interventions: Device: EW Tricuspid Transcatheter Repair System

Registration Number: NCT02787408

Lead Sponsor: Edwards Lifesciences

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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:
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)
Moderate or greater tricuspid valve stenosis
Untreated clinically significant coronary artery disease requiring immediate revascularization
Any therapeutic invasive cardiac procedure performed within 30 days of the scheduled implant procedure
Patients not already receiving dialysis with renal insufficiency (eGFR <25) per lab test ≤ 48 hours prior to scheduled implant procedure
Myocardial infarction within 30 days of scheduled implant procedure
Hemodynamic instability within 30 days of scheduled implant procedure
Patient requiring surgery under general anesthesia for any reason within 90 days of scheduled implant procedure
Severe left ventricular dysfunction with ejection fraction < 25% within 90 days of scheduled implant procedure
Patients with pulmonary artery systolic pressure > 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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EW Tricuspid Transcatheter Repair System	EW Tricuspid Transcatheter Repair System	Edwards (EW) Tricuspid Transcatheter Repair System

Primary Outcome Measures

Name	Time	Method
All-cause Mortality	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 Outcome Measures

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

Trial Locations

Locations (11): St. Paul's Hospital, Providence Health Care Research Institute
🇨🇦
Vancouver, British Columbia, Canada
Inselspital, Universitätsspital Bern
🇨🇭
Bern, Switzerland
Toronto General Hospital
🇨🇦
Toronto, Ontario, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite Laval
🇨🇦
Quebec, Canada
Institut Hospitalier Jacques Cartier
🇫🇷
Massy, France
Universitäts-Herzzentrum Freiburg - Bad Krozingen
🇩🇪
Bad Krozingen, Germany
Hōpital Charles Nicolle
🇫🇷
Rouen, France
Munich University Clinic, Ludwig-Maximilian University
🇩🇪
Munich, Germany
Charite-Universitätsmedzin Berlin
🇩🇪
Berlin, Germany
Hygeia Hospital
🇬🇷
Athens, Greece
Asklepios Klinik St. Georg
🇩🇪
Hamburg, Germany