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

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ClinicalTrials.gov Identifier: NCT02787408
Recruitment Status : Active, not recruiting
First Posted : June 1, 2016
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
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.

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.

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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

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787408


Locations
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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

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02787408     History of Changes
Other Study ID Numbers: 2015-09
First Posted: June 1, 2016    Key Record Dates
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:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases