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Trial record 1 of 1 for:    SUMMIT Tendyne
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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)

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 : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE February 8, 2018
First Posted Date  ICMJE February 14, 2018
Last Update Posted Date January 8, 2021
Actual Study Start Date  ICMJE June 15, 2018
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
  • Randomized Cohort [ Time Frame: 1 year ]
    Survival free of heart failure hospitalization at 12 months post index procedure
  • Non-Randomized Cohort [ Time Frame: 1 year ]
    A composite of all-cause mortality, cardiovascular-related hospitalizations, stroke or mitral valve reintervention or reoperation
  • Mitral Annular Calcification (MAC) Cohort [ Time Frame: 1 year ]
    Survival free of heart failure hospitalization at 12 months post index procedure
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
  • Change from baseline in distance walked, as measured by the 6 Minute Walk Test (6MWT) [ Time Frame: 1 year ]
  • Change from baseline in quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 1 year ]
  • Change from baseline in health outcomes, as measured by the EQ-5D [ Time Frame: 1 year ]
  • • Change from baseline in health outcomes, as measured by the 12-item Short Form Health Survey (SF-12) [ Time Frame: 1 year ]
  • Change from baseline in New York Heart Association Classification [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Official Title  ICMJE Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
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.

The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne 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 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 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-randomized cohort.

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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mitral Regurgitation
  • Mitral Insufficiency
  • Mitral Valve Insufficiency
  • Cardiovascular Diseases
  • Valve Disease, Heart
  • Heart Valve Diseases
  • Functional Mitral Regurgitation
  • Degenerative Mitral Valve Disease
Intervention  ICMJE
  • Device: Tendyne Mitral Valve System
    Mitral valve replacement
  • Device: MitraClip System
    Percutaneous mitral valve repair using the MitraClip system.
Study Arms  ICMJE
  • Experimental: Randomized Cohort - Treatment Group
    Treatment of mitral regurgitation with the Tendyne Mitral Valve System
    Intervention: Device: Tendyne Mitral Valve System
  • Active Comparator: Randomized Cohort - Control Group
    Treatment of mitral regurgitation within commercially approved MitraClip system indications
    Intervention: Device: MitraClip System
  • Experimental: Non-Randomized Cohort
    Treatment of mitral regurgitation with the Tendyne Mitral Valve System
    Intervention: Device: Tendyne Mitral Valve System
  • Experimental: Mitral Annular Calcification (MAC) Cohort
    Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Mitral Valve System
    Intervention: Device: Tendyne Mitral Valve System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 8, 2019)
958
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE June 2026
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kayla Dellefratte +1 (669)214-9748 SUMMIT.Trial@abbott.com
Contact: Dana Haudek +1 (928)925-4054 dana.haudek@abbott.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03433274
Other Study ID Numbers  ICMJE CS0004-P
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gorav Ailawadi, MD University of Virginia
Principal Investigator: Jason Rogers, MD University of California, Davis
Study Director: Kartik Sundareswaran, PhD Abbott Structural Heart
PRS Account Abbott Medical Devices
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP