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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 : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Tendyne Holdings, Inc.

Brief Summary:

Prospective, controlled, multicenter clinical investigation with two trial arms: surgical and non-surgical. Subjects in the surgical arm will be randomized in a 2:1 ratio to the trial device or to conventional mitral valve surgery. Subjects in the non-surgical arm 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: Surgical mitral valve repair or replacement Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1010 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: Surgical Candidate Arm - Treatment Group
Treatment of mitral regurgitation with the Tendyne Mitral Valve System
Device: Tendyne Mitral Valve System
mitral valve replacement

Active Comparator: Surgical Candidate Arm - Control Group
Treatment of mitral regurgitation with standard of care repair or total chordal-sparing replacement
Device: Surgical mitral valve repair or replacement
mitral valve repair (with remodeling annuloplasty) or total chordal-sparing mitral valve replacement

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




Primary Outcome Measures :
  1. A composite of all-cause mortality, cardiovascular-related hospitalizations, stroke or mitral valve reintervention or reoperation [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Freedom from mitral regurgitation > 2+ and without mitral valve reintervention or reoperation [ Time Frame: 1 year ]
  2. Days alive and out of hospital [ Time Frame: 30 days and 1 year ]
  3. Change from baseline in quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 1 year ]
  4. Change from baseline in distance walked, as measured by the 6 Minute Walk Test [ Time Frame: 1 year ]
  5. Change from baseline in New York Heart Association Classification [ Time Frame: 1 year ]
  6. Change from baseline in health outcomes, as measured by the EQ-5D [ 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, severe mitral regurgitation
  • 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:

  • 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
  • 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
Contact: David Pomfret +1 (651) 289-5500 SUMMIT.Trial@abbott.com
Contact: Josh Schumacher +1 (651) 289-5500 SUMMIT.Trial@abbott.com

Locations
United States, Alabama
Princeton Baptist Medical Center Recruiting
Birmingham, Alabama, United States, 35211
Contact: Kathy Phillips, RN       Kathy.Phillips@BHSALA.com   
Principal Investigator: Mustafa Ahmed, M.D.         
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Stephanie Mullin, RN, BSN, PHN, CCRC       Stephanie.Mullin@med.usc.edu   
Principal Investigator: Mark Cunningham, M.D.         
University of California - Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Kimberley Book, BS, RN, CCRP       kabook@ucdavis.edu   
Principal Investigator: Jason Rogers, M.D.         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Therese Jones, MS       therese.l.jones@ucdenver.edu   
Principal Investigator: John Carroll, M.D.         
United States, Florida
Tallahassee Research Institute Recruiting
Tallahassee, Florida, United States, 32308
Contact: Rebecca Plasay, RN, BSN       Rebecca.Plasay@tmh.org   
Principal Investigator: Wayne Batchelor, M.D.         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Elizabeth Charles, MPH       elizabeth.z.charles@emory.edu   
Principal Investigator: Vasilis Babaliaros, M.D.         
United States, Kansas
Cardiovascular Research Institute of Kansas Recruiting
Wichita, Kansas, United States, 67226
Contact: Elizabeth Persels, RN       elizabeth.persels@cckheart.com   
Principal Investigator: Bassem Chehab, M.D.         
United States, Maryland
Medstar Health Research Institute Recruiting
Baltimore, Maryland, United States, 21218
Contact: Caroline Barnes, RN, MPH       Caroline.G.Barnes@medstar.net   
Principal Investigator: Vinod Thourani, M.D.         
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Sara Olson, RN, BSN, CCRC       Sara.Olson@allina.com   
Principal Investigator: Paul Sorajja, M.D.         
United States, New York
Southside Hospital Recruiting
Bay Shore, New York, United States, 11706
Contact: Barbara Shannon, RN, CCRC       BShannon@northwell.edu   
Principal Investigator: Robert Kalimi, M.D.         
Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: Efstathia Mihelis, PA-C       EMihelis@northwell.edu   
Principal Investigator: Robert Kalimi, M.D.         
Sub-Investigator: Chad Kliger, M.D.         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Sally Aberle, RN, BSN, CCRC       Sally.Aberle@atriumhealth.org   
Principal Investigator: Michael Rinaldi, M.D.         
United States, Pennsylvania
Alleghany General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Tracy Sprik, RN       Tracy.SPIRK@ahn.org   
Principal Investigator: Walter McGregor, M.D.         
United States, Texas
Baylor Research Institute Recruiting
Dallas, Texas, United States, 75226
Contact: Susan Aston, RN       Susan.Aston@BSWHealth.org   
Principal Investigator: Paul Grayburn, M.D.         
United States, Virginia
University of Virginia Medical Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Linda Bailes, RN       LGS2M@hscmail.mcc.virginia.edu   
Principal Investigator: Gorav Ailawadi, M.D.         
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Melissa Crigler, BSN, RN       mailto:CriglerM@wvumedicine.org   
Principal Investigator: Vinay Badhwar         
Sponsors and Collaborators
Tendyne Holdings, Inc.
Investigators
Principal Investigator: Gorav Ailawadi, M.D. University of Virginia
Principal Investigator: Jason Rogers, M.D. University of California, Davis

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: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Cardiovascular Diseases
Vomiting
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Signs and Symptoms, Digestive
Signs and Symptoms