History of Changes for Study: NCT02321514
Expanded Clinical Study of the Tendyne Mitral Valve System
Latest version (submitted July 3, 2020) on
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Study Record Versions
Version A B Submitted Date Changes
1 December 19, 2014 None (earliest Version on record)
2 April 7, 2015 Study Status and Contacts/Locations
3 April 15, 2015 Contacts/Locations, Eligibility and Study Status
4 July 7, 2015 Contacts/Locations and Study Status
5 August 27, 2015 Study Status and Contacts/Locations
6 October 21, 2015 Study Status and Contacts/Locations
7 November 19, 2015 Study Status and Contacts/Locations
8 May 18, 2016 Contacts/Locations, Study Status, Eligibility, Study Design, Study Description and Study Identification
9 October 18, 2017 Contacts/Locations, Study Status and Study Identification
10 November 15, 2017 Contacts/Locations and Study Status
11 November 17, 2017 Study Description and Study Status
12 January 30, 2018 Study Status and Contacts/Locations
13 March 20, 2018 Contacts/Locations and Study Status
14 April 30, 2018 Study Status, Contacts/Locations and Study Description
15 September 4, 2018 Contacts/Locations and Study Status
16 October 30, 2018 Contacts/Locations and Study Status
17 December 13, 2018 Contacts/Locations and Study Status
18 February 19, 2019 Study Status and Contacts/Locations
19 July 3, 2019 Contacts/Locations and Study Status
20 October 16, 2019 Study Status and Study Identification
21 January 8, 2020 Contacts/Locations, Study Status and Study Design
22 February 12, 2020 Recruitment Status, Contacts/Locations and Study Status
23 April 27, 2020 Study Status
24 July 3, 2020 Study Status
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Study NCT02321514
Submitted Date:  October 16, 2019 (v20)

Open or close this module Study Identification
Unique Protocol ID: CS-03
Brief Title: Expanded Clinical Study of the Tendyne Mitral Valve System
Official Title: Expanded Clinical Study of the Tendyne Mitral Valve System
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2019
Overall Status: Recruiting
Study Start: November 2014
Primary Completion: December 2019 [Anticipated]
Study Completion: December 2024 [Anticipated]
First Submitted: December 10, 2014
First Submitted that
Met QC Criteria:
December 19, 2014
First Posted: December 22, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 16, 2019
Last Update Posted: October 17, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Abbott Medical Devices
Responsible Party: Sponsor
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to generate initial insights into the safety and performance of the Tendyne Mitral Valve System. The study includes adult patients with symptomatic mitral regurgitation who are not suitable candidates for conventional mitral valve repair or replacement. The study will include up to 350 subjects at up to 40 centers. Follow-up evaluations will be conducted through 5 years post implantation.
Detailed Description:
Open or close this module Conditions
Conditions: Mitral Valve Regurgitation
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 110 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Tendyne Mitral Valve System
Transcatheter mitral valve replacement
Device: Tendyne Mitral Valve System
Transcatheter mitral valve replacement
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Safety assessed by freedom from device or procedure related adverse events

[Time Frame: 30-days]
2. Performance assessed by freedom from device malfunction

[Time Frame: 30-days]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No

Inclusion Criteria:

  1. Severe mitral regurgitation of primary or secondary etiology
  2. NYHA functional Class ≥ II. If IV, patient must be ambulatory
  3. Heart team determines patient is not a suitable candidate for traditional surgical treatment
  4. Age 18 years or older

Exclusion Criteria:

  1. Severe mitral calcification or mitral stenosis
  2. Chest condition that prevents transapical access
  3. Prior surgical or interventional treatment of mitral or aortic valves
Open or close this module Contacts/Locations
Central Contact Person: David Pomfret
Central Contact Backup: Ankita Bhalla
Locations: United States, Arizona
Honor Health Scottsdale Shea Medical Center
[Active, not recruiting]
Scottsdale, Arizona, United States, 85260
United States, District of Columbia
MedStar Washington Hospital
[Active, not recruiting]
Washington, District of Columbia, United States, 20010
United States, Florida
Morton Plant Mease Health Care
Clearwater, Florida, United States, 33756
Delray Medical Center
[Active, not recruiting]
Delray Beach, Florida, United States, 33484
United States, Georgia
Emory University Hospital
[Active, not recruiting]
Atlanta, Georgia, United States, 30322
United States, Illinois
Northshore University Health System
[Active, not recruiting]
Evanston, Illinois, United States, 60201
United States, Michigan
Henry Ford Hospital
[Active, not recruiting]
Detroit, Michigan, United States, 48202
United States, Minnesota
Abbott Northwestern Hospital
[Active, not recruiting]
Minneapolis, Minnesota, United States, 55407
United States, Ohio
Cleveland Clinic Foundation
[Active, not recruiting]
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pinnacle Health - Harrisburg Hospital
[Active, not recruiting]
Harrisburg, Pennsylvania, United States, 17104
United States, Texas
Baylor Heart & Vascular Center
[Active, not recruiting]
Dallas, Texas, United States, 75226
United States, West Virginia
West Virginia University
[Active, not recruiting]
Morgantown, West Virginia, United States, 26506
Flinders Medical Center
Bedford Park, Australia, 5042
Contact:Contact: Jane Collins
Contact:Principal Investigator: Ajay Sinhal, MD
Prince Charles Hospital
Chermside, Australia
Contact:Contact: Maricel Roxas
St. Vincent's Hospital
Sydney, Australia
Contact:Contact: Erika O'Dea
Contact:Principal Investigator: David Muller
Bordeaux University Hospital
Bordeaux, France
Contact:Contact: Cecile Jore
Contact:Principal Investigator: Louis Labrousse
CHRU de Lille
Lille, France, 59000
Contact:Contact: Thomas Modine Thomas.MODINE@CHRU-LILLE.FR
Contact:Principal Investigator: Thomas Modine
Lyon University Hospital
Lyon, France
Contact:Contact: Carine Flys
Contact:Principal Investigator: Jean-Francois Obadia
Rennes University Hospital
Rennes, France
Contact:Contact: Emmanuelle Babin-Lerede
Contact:Contact: Laurence Le Bouquin
Clinique Pasteur
Toulouse, France, 31300
Contact:Contact: Frederic Petit
Contact:Principal Investigator: Nicolas Dumonteil
Deutsche Herzzentrum Berlin
Berlin, Germany, 13353
Contact:Contact: Thomas Haese 49 30 4593-2270
Contact:Principal Investigator: Stephan Jacobs
Universitätsklinikum Bonn
Bonn, Germany, 53105
Contact:Contact: Sonja Parthier 0049-(0)228-287-14305
Contact:Principal Investigator: Prof Dr med Georg Nickenig
University Hospital Dresden
Dresden, Germany
Contact:Contact: Cornelia Fritz
Contact:Principal Investigator: Axel Linke
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590
Contact:Contact: Heike Strohschnitter 49 (0) 69 - 6301 3724
Contact:Principal Investigator: Prof. Thomas Walther
University Heart Center Hamburg
Hamburg, Germany, 20251
Contact:Contact: Sonja Stolze
Contact:Contact: Kristen Suhr
Contact:Principal Investigator: Edith Lubos
Leipzig Heart Center
Leipzig, Germany, 04289
Contact:Contact: Mandy Ludwig +49 341 865 1573
Contact:Principal Investigator: Jorg Seeburger
Universitätsmedizin Mainz
Mainz, Germany, 55131
Contact:Contact: Ralph Stephan von Bardeleben, MD
University of Munich
Munich, Germany
Contact:Contact: Andrea Englemeier
Contact:Principal Investigator: Joerg Hausleiter
Universitätsmedizin Rostock
Rostock, Germany, 18057
Contact:Contact: Kerry Wegner 49 (0) 381 / 494 - 7748
Contact:Principal Investigator: Ince Hueseyin
Ospedale Ferrarotta - Catania
Catania, Italy, 95124
Contact:Contact: Marco Barbanti
Contact:Principal Investigator: Corrado Tamburino
San Raffaele
Milan, Italy, 20132
Contact:Contact: Paolo Denti
Contact:Principal Investigator: Paolo Denti
Pisa University
Pisa, Italy
Contact:Contact: Chiara Primerano
Contact:Principal Investigator: Anna Petronio
Humanitas Research Hospital
Rozzano, Italy, 56-20089
Contact:Contact: Daniela Cattani
Contact:Principal Investigator: Lucia Torracca, MD
San Donato
San Donato Milanese, Italy, 20097
Contact:Contact: Francesco Bedogni
Contact:Principal Investigator: Francesco Bedogni
St. Antonius Hospital
Nieuwegein, Netherlands
Contact:Contact: Jan van der Heyden
Contact:Principal Investigator: Jan van der Heyden
Oslo University Hospital
Oslo, Norway, 0424
Contact:Contact: Gro Sorensen
Contact:Principal Investigator: Gry Dahle, MD
Karolinksa University Hospital
Solna, Sweden, 17176
Contact:Contact: David Ersgard
Contact:Principal Investigator: Magnus Settergren
University Hospital of Zurich
Zürich, Switzerland, 8091
Contact:Contact: Alice Birkner
Contact:Principal Investigator: Francesco Maisano
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Contact:Contact: ShuFang Wang
Contact:Principal Investigator: Alison Duncan, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Available IPD/Information:

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