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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03433274
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : March 23, 2023
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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Brief Summary:

Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP). 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-repairable, Severe MAC, and Severe MAC CAP cohorts will receive the trial device.

The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.

This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort.

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

Study Design
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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 Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: Randomized Cohort - Treatment Group
Treatment of mitral regurgitation with the Tendyne Transcatheter 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-repairable Cohort
Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System
 Device: Tendyne Mitral Valve System
Mitral valve replacement
Experimental: Severe Mitral Annular Calcification (MAC) Cohort
Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System
 Device: Tendyne Mitral Valve System
Mitral valve replacement
Experimental: Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP) Cohort
Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System after the completion of enrollment in the Severe MAC Cohort
 Device: Tendyne Mitral Valve System
Mitral valve replacement


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

  2. Non-repairable Cohort [ Time Frame: 1 year ]
    Survival free of heart failure hospitalization at 12 months post index procedure

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

  4. Severe MAC Continued Access Protocol (MAC CAP) 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 ]

Eligibility Criteria
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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
Contacts and Locations
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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: Kayla Dellefratte +1 (669)214-9748 SUMMIT.Trial@abbott.com
Contact: Leslie Ornelas +1 (602)692-5047 leslie.ornelas@abbott.com

Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Gorav Ailawadi, MD University of Michigan
Principal Investigator: Jason Rogers, MD University of California, Davis
Study Director: Ryan Palmer, PhD Abbott Structural Heart
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03433274    
Other Study ID Numbers: CS0004-P
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: March 23, 2023
Last Verified: March 2023
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
Additional relevant MeSH terms:
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Cardiovascular Diseases
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases