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Expanded Clinical Study of the Tendyne Mitral Valve System

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ClinicalTrials.gov Identifier: NCT02321514
Recruitment Status : Recruiting
First Posted : December 22, 2014
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Tendyne Holdings, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Device: Tendyne Mitral Valve System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Expanded Clinical Study of the Tendyne Mitral Valve System
Study Start Date : November 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Tendyne Mitral Valve System
Transcatheter mitral valve replacement
 Device: Tendyne Mitral Valve System
Transcatheter mitral valve replacement


Outcome Measures
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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 ]

Eligibility Criteria
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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:

  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
Contacts and Locations
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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): NCT02321514


Contacts
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Contact: David Pomfret david.pomfret@abbott.com
Contact: Ankita Bhalla ankita.bhalla@abbott.com

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Sponsors and Collaborators
Tendyne Holdings, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tendyne Holdings, Inc.
ClinicalTrials.gov Identifier: NCT02321514     History of Changes
Other Study ID Numbers: CS-03
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases