Expanded Clinical Study of the Tendyne Mitral Valve System

July 8, 2025 updated by: Abbott Medical Devices
The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

191

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia, 5042
        • Flinders Medical Center
      • Chermside, Australia
        • Prince Charles Hospital
      • Sydney, Australia
        • St. Vincent's Hospital
  • France
      • Bordeaux, France
        • Bordeaux University Hospital
      • Lille, France, 59000
        • CHRU de Lille
      • Lyon, France
        • Lyon University Hospital
      • Rennes, France
        • Rennes University Hospital
      • Toulouse, France, 31300
        • Clinique Pasteur
  • Germany
      • Berlin, Germany, 13353
        • Deutsche Herzzentrum Berlin
      • Bonn, Germany, 53105
        • Universitatsklinikum Bonn
      • Dresden, Germany
        • University Hospital Dresden
      • Frankfurt, Germany, 60590
        • Universitatsklinikum Frankfurt
      • Hamburg, Germany, 20251
        • University Heart Center Hamburg
      • Leipzig, Germany, 04289
        • Leipzig Heart Center
      • Mainz, Germany, 55131
        • University Medical Center Mainz
      • Munich, Germany
        • Ludwig-Maximilians-Universität München (LMU)
      • Rostock, Germany, 18057
        • University of Rostock
  • Italy
      • Catania, Italy, 95124
        • Ospedale Ferrarotta - Catania
      • Milan, Italy, 20132
        • San Raffaele
      • Pisa, Italy
        • Pisa University
      • Rozzano, Italy, 56-20089
        • HUMANITAS Research Hospital
      • San Donato Milanese, Italy, 20097
        • San Donato
  • Netherlands
      • Nieuwegein, Netherlands
        • St. Antonius Hospital
  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital
  • Sweden
      • Solna, Sweden, 17176
        • Karolinksa University Hospital
  • Switzerland
      • Zürich, Switzerland, 8091
        • University Hospital of Zurich
  • United Kingdom
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Honor Health Scottsdale Shea Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital
    • Florida
      • Clearwater, Florida, United States, 33756
        • Morton Plan Mease Health Care
      • Delray Beach, Florida, United States, 33484
        • Delray Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University Health System
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
    • New York
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17104
        • Pinnacle Health - Harrisburg Hospital
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Heart & Vascular Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Severe mitral regurgitation of primary or secondary etiology according to MVARC (Mitral Valve Academic Research Consortium) 2015 defined as:

    • For Degenerative MR: EROA ≥ 40 mm^2 or regurgitant volume ≥ 60ml
    • For Secondary MR: EROA ≥ 20 mm^2 or regurgitant volume ≥ 30ml
  2. New York Heart Association (NYHA) functional Class ≥ II while on guideline directed medical therapy (GMDT), including device therapy (CRT) if indicated.
  3. Heart team determines patient is not a suitable candidate for traditional surgical treatment according to valid guidelines.
  4. Age 18 years or older.

Exclusion Criteria:

  1. Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass.
  2. Left Ventricle (LV) or Left Atrium (LA) thrombus.
  3. Patient has a chest condition that prevents transapical access.
  4. Left ventricular ejection fraction (LVEF) less than 30% by echocardiogram.
  5. Left Ventricular End Diastolic Diameter (LVEDD) > 7.0 cm.
  6. Prior surgical or interventional treatment of mitral or aortic valves (e.g. valve repair or replacement, MitraClip, edge to edge repair, aortic balloon valvuloplasty, etc.).
  7. Any planned surgery or interventional procedure within the period of 30 days prior to 30 days following the implant procedure. This includes any planned concomitant cardiovascular procedure such as PCI, pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.
  8. Cardiac resynchronization therapy device or implantable pulse generator implanted within three months of planned implant procedure.
  9. Myocardial Infarction (MI) within 30 days of the planned implant procedure.
  10. Symptomatic, unresolved multi-vessel coronary artery disease (CAD) or unprotected left main coronary artery disease requiring stenting or Coronary Artery Bypass Grafting (CABG).
  11. Cerebrovascular accident (CVA) within six months of planned implant procedure.
  12. Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound).
  13. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
  14. Severe tricuspid regurgitation, tricuspid valve disease requiring surgery or severe right ventricular dysfunction.
  15. Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
  16. Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated.
  17. History of endocarditis within six months of planned implant procedure.
  18. Active systemic infection requiring antibiotic therapy.
  19. Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anti-coagulation therapy) which cannot be adequately managed medically or hypersensitivity to nickel or titanium.
  20. Patient is undergoing hemodialysis due to chronic renal failure.
  21. Patient has pulmonary arterial hypertension (fixed PAS >70mmHg).
  22. Patient has COPD and is on home oxygen.
  23. Patient refuses blood transfusions.
  24. Pregnant, lactating, or planning pregnancy within next 12 months.
  25. Participating or planning participation in an investigational drug or another device study.
  26. Patient or legal guardian unable or unwilling to give informed consent.
  27. Patient unable or unwilling to comply with study required testing and follow-up visits.
  28. Patients with non-cardiac co-morbidities that are likely to result in a life expectancy of less than one year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tendyne Mitral Valve System
Patients will undergo transcatheter mitral valve replacement
Device: Tendyne Mitral Valve System
Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Endpoint: Number of Participants With Composite of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs)
Time Frame: 30 days post-index procedure

Device success and freedom from the following device- or procedure-related serious adverse events (SAEs) at 30 days post the index procedure, will be classified by the Clinical Events Committee (CEC):

  • Cardiovascular death
  • Reintervention caused by valve-related dysfunction
  • Disabling stroke
  • Myocardial infarction (MI)
  • Life-threatening bleeding (BARC Type 2, 3, and 5)
  • Major Vascular Complications
  • Renal failure requiring dialysis
  • Other device-related SAEs
  • Other procedure-related SAEs
30 days post-index procedure
Performance Endpoint: Number of Participants With MR Grade ≤ 2
Time Frame: 30 days post-index procedure

Proportion of subjects with mitral regurgitation (MR) grade ≤ 2, per echocardiography core laboratory will be assessed.

MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.
30 days post-index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

December 10, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (Estimated)

December 22, 2014

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 8, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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