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Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT)

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ClinicalTrials.gov Identifier: NCT03433274
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Tendyne Holdings, Inc.

Brief Summary:

Prospective, controlled, multicenter clinical investigation with three trial cohorts: Randomized, Non-Randomized, and Mitral Annular Calcification (MAC). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-Randomized and MAC cohorts will receive the trial device.

Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.


Condition or disease Intervention/treatment Phase
Mitral Regurgitation Mitral Insufficiency Mitral Valve Insufficiency Cardiovascular Diseases Valve Disease, Heart Heart Valve Diseases Functional Mitral Regurgitation Degenerative Mitral Valve Disease Device: Tendyne Mitral Valve System Device: MitraClip System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 958 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2026

Arm Intervention/treatment
Experimental: Randomized Cohort - Treatment Group
Treatment of mitral regurgitation with the Tendyne Mitral Valve System
Device: Tendyne Mitral Valve System
Mitral valve replacement

Active Comparator: Randomized Cohort - Control Group
Treatment of mitral regurgitation within commercially approved MitraClip system indications
Device: MitraClip System
Percutaneous mitral valve repair using the MitraClip system.

Experimental: Non-Randomized Cohort
Treatment of mitral regurgitation with the Tendyne Mitral Valve System
Device: Tendyne Mitral Valve System
Mitral valve replacement

Experimental: Mitral Annular Calcification (MAC) Cohort
Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Mitral Valve System
Device: Tendyne Mitral Valve System
Mitral valve replacement




Primary Outcome Measures :
  1. Randomized Cohort [ Time Frame: 1 year ]
    Survival free of heart failure hospitalization at 12 months post index procedure

  2. Non-Randomized Cohort [ Time Frame: 1 year ]
    A composite of all-cause mortality, cardiovascular-related hospitalizations, stroke or mitral valve reintervention or reoperation

  3. Mitral Annular Calcification (MAC) Cohort [ Time Frame: 1 year ]
    Survival free of heart failure hospitalization at 12 months post index procedure


Secondary Outcome Measures :
  1. Change from baseline in distance walked, as measured by the 6 Minute Walk Test (6MWT) [ Time Frame: 1 year ]
  2. Change from baseline in quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 1 year ]
  3. Change from baseline in health outcomes, as measured by the EQ-5D [ Time Frame: 1 year ]
  4. • Change from baseline in health outcomes, as measured by the 12-item Short Form Health Survey (SF-12) [ Time Frame: 1 year ]
  5. Change from baseline in New York Heart Association Classification [ Time Frame: 1 year ]


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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:

  • Symptomatic, moderate-to-severe or severe mitral regurgitation, or severe mitral annular calcification (MAC)
  • NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)
  • The local site heart team determines that the subject has been adequately treated per applicable standards
  • Not a member of a vulnerable population

Exclusion Criteria:

  • Mitral valvular vegetation or mass
  • Left ventricular ejection fraction < 25%
  • Left ventricular end diastolic diameter > 7.0 cm
  • Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material
  • Aortic valve disease requiring surgery or transcatheter intervention
  • Severe tricuspid regurgitation or any tricuspid valve disease requiring surgery or transcatheter intervention
  • Any planned surgical / interventional procedure within 60 day prior to or following subject randomization
  • Subject undergoing hemodialysis due to chronic renal failure
  • Mitral pathoanatomy and left ventricular outflow tract anatomy deemed not suitable for Trial device implantation
  • Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months

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): NCT03433274


Contacts
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Contact: Josh Schumacher +1 (651) 289-5500 SUMMIT.Trial@abbott.com
Contact: Ankita Bhalla +1 (651) 289-5500 SUMMIT.Trial@abbott.com

  Show 29 Study Locations
Sponsors and Collaborators
Tendyne Holdings, Inc.
Investigators
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Principal Investigator: Gorav Ailawadi, M.D. University of Virginia
Principal Investigator: Jason Rogers, M.D. University of California, Davis
Principal Investigator: Paul Sorajja, M.D. Minneapolis Heart Institute
Principal Investigator: Vinod Thourani, M.D. Piedmont Healthcare

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Responsible Party: Tendyne Holdings, Inc.
ClinicalTrials.gov Identifier: NCT03433274     History of Changes
Other Study ID Numbers: CS0004-P
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases