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Status:

COMPLETED

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

Lead Sponsor:

Edwards Lifesciences

Conditions:

Tricuspid Valve Regurgitation

Eligibility:

All Genders

18+ years

Phase:

NA

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 regurgitati...

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 regurgitati...

Eligibility Criteria

Inclusion

  • 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 \< 2.14 cm2 (9 mm device) or \< 2.63 cm2 (12 mm device) or \< 3.27cm2 (15 mm device) as measured by transthoracic echocardiography
  • Sub-valvular structures/anatomy that would preclude from proper anchor or coaptation device placement, positioning and retrieval
  • 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

    Key Trial Info

    Start Date :

    September 14 2016

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 14 2020

    Estimated Enrollment :

    25 Patients enrolled

    Trial Details

    Trial ID

    NCT02787408

    Start Date

    September 14 2016

    End Date

    December 14 2020

    Last Update

    October 25 2022

    Active Locations (11)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (11 locations)

    1

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

    Vancouver, British Columbia, Canada, V6E 1M7

    2

    Toronto General Hospital

    Toronto, Ontario, Canada, M5G 2C4

    3

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

    Québec, Canada, G1V 4G5

    4

    Institut Hospitalier Jacques Cartier

    Massy, France, 91300