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History of Changes for Study: NCT02321514
Expanded Clinical Study of the Tendyne Mitral Valve System
Latest version (submitted July 3, 2020) on ClinicalTrials.gov
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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
Collaborators:
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
Keywords:
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
Criteria:

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
Email: david.pomfret@abbott.com
Central Contact Backup: Ankita Bhalla
Email: ankita.bhalla@abbott.com
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
[Withdrawn]
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
Australia
Flinders Medical Center
[Recruiting]
Bedford Park, Australia, 5042
Contact:Contact: Jane Collins Jane.Collins@sa.gov.au
Contact:Principal Investigator: Ajay Sinhal, MD
Prince Charles Hospital
[Recruiting]
Chermside, Australia
Contact:Contact: Maricel Roxas maricel.roxas@health.qld.gov.au
St. Vincent's Hospital
[Recruiting]
Sydney, Australia
Contact:Contact: Erika O'Dea erika.odea@svha.org.au
Contact:Principal Investigator: David Muller
France
Bordeaux University Hospital
[Recruiting]
Bordeaux, France
Contact:Contact: Cecile Jore cecilejore@chu-bordeaux.fr
Contact:Principal Investigator: Louis Labrousse
CHRU de Lille
[Recruiting]
Lille, France, 59000
Contact:Contact: Thomas Modine Thomas.MODINE@CHRU-LILLE.FR
Contact:Principal Investigator: Thomas Modine
Lyon University Hospital
[Recruiting]
Lyon, France
Contact:Contact: Carine Flys mailto:carine.flys@chu-lyon.fr
Contact:Principal Investigator: Jean-Francois Obadia
Rennes University Hospital
[Recruiting]
Rennes, France
Contact:Contact: Emmanuelle Babin-Lerede Emmanuelle.BABIN-LEREDE@chu-rennes.fr
Contact:Contact: Laurence Le Bouquin Laurence.LE.BOUQUIN@chu-rennes.fr
Clinique Pasteur
[Recruiting]
Toulouse, France, 31300
Contact:Contact: Frederic Petit
Contact:Contact: frederic.petit@aphp.fr
Contact:Principal Investigator: Nicolas Dumonteil
Germany
Deutsche Herzzentrum Berlin
[Recruiting]
Berlin, Germany, 13353
Contact:Contact: Thomas Haese 49 30 4593-2270 haese@dhzb.de
Contact:Principal Investigator: Stephan Jacobs
Universitätsklinikum Bonn
[Recruiting]
Bonn, Germany, 53105
Contact:Contact: Sonja Parthier 0049-(0)228-287-14305 sonja.parthier@ukbonn.de
Contact:Principal Investigator: Prof Dr med Georg Nickenig
University Hospital Dresden
[Recruiting]
Dresden, Germany
Contact:Contact: Cornelia Fritz Cornelia.fritz@tu-dresden.de
Contact:Principal Investigator: Axel Linke
Universitätsklinikum Frankfurt
[Recruiting]
Frankfurt, Germany, 60590
Contact:Contact: Heike Strohschnitter 49 (0) 69 - 6301 3724 heike.strohschnitter@kgu.de
Contact:Principal Investigator: Prof. Thomas Walther
University Heart Center Hamburg
[Recruiting]
Hamburg, Germany, 20251
Contact:Contact: Sonja Stolze s.stolze@uke.de
Contact:Contact: Kristen Suhr k.suhr@uke.de
Contact:Principal Investigator: Edith Lubos
Leipzig Heart Center
[Recruiting]
Leipzig, Germany, 04289
Contact:Contact: Mandy Ludwig +49 341 865 1573 mandy.Ludwig@leipzig-heart.de
Contact:Principal Investigator: Jorg Seeburger
Universitätsmedizin Mainz
[Recruiting]
Mainz, Germany, 55131
Contact:Contact: Ralph Stephan von Bardeleben, MD stephan.von_bardeleben@unimedizin-mainz.de
University of Munich
[Recruiting]
Munich, Germany
Contact:Contact: Andrea Englemeier Andrea.Englmaier@med.uni-muenchen.de
Contact:Principal Investigator: Joerg Hausleiter
Universitätsmedizin Rostock
[Recruiting]
Rostock, Germany, 18057
Contact:Contact: Kerry Wegner 49 (0) 381 / 494 - 7748 kerry.wegner@med.uni-rostock.de
Contact:Principal Investigator: Ince Hueseyin
Italy
Ospedale Ferrarotta - Catania
[Recruiting]
Catania, Italy, 95124
Contact:Contact: Marco Barbanti mbarbanti83@gmail.com
Contact:Principal Investigator: Corrado Tamburino
San Raffaele
[Recruiting]
Milan, Italy, 20132
Contact:Contact: Paolo Denti
Contact:Principal Investigator: Paolo Denti
Pisa University
[Recruiting]
Pisa, Italy
Contact:Contact: Chiara Primerano chiaraprim@gmail.com
Contact:Principal Investigator: Anna Petronio
Humanitas Research Hospital
[Recruiting]
Rozzano, Italy, 56-20089
Contact:Contact: Daniela Cattani daniela.cattani@humanitas.it
Contact:Principal Investigator: Lucia Torracca, MD
San Donato
[Recruiting]
San Donato Milanese, Italy, 20097
Contact:Contact: Francesco Bedogni
Contact:Principal Investigator: Francesco Bedogni
Netherlands
St. Antonius Hospital
[Recruiting]
Nieuwegein, Netherlands
Contact:Contact: Jan van der Heyden
Contact:Principal Investigator: Jan van der Heyden
Norway
Oslo University Hospital
[Recruiting]
Oslo, Norway, 0424
Contact:Contact: Gro Sorensen gsorense@ous-hf.no
Contact:Principal Investigator: Gry Dahle, MD
Sweden
Karolinksa University Hospital
[Recruiting]
Solna, Sweden, 17176
Contact:Contact: David Ersgard
Contact:Principal Investigator: Magnus Settergren
Switzerland
University Hospital of Zurich
[Recruiting]
Zürich, Switzerland, 8091
Contact:Contact: Alice Birkner alice.birkner@usz.ch
Contact:Principal Investigator: Francesco Maisano
United Kingdom
Royal Brompton Hospital
[Recruiting]
London, United Kingdom, SW3 6NP
Contact:Contact: ShuFang Wang S.Wang@rbht.nhs.uk
Contact:Principal Investigator: Alison Duncan, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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