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Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02428010
Recruitment Status : Terminated (Site has not reliably responded Medtronic team since the transition from sponsor Twelve. No data entry completed since February 2018. Last study subject passed final study visit window. No data is expected to be entered.)
First Posted : April 28, 2015
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Study Description
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Brief Summary:
Study to evaluate the safety and performance of the Twelve TMVR System

Condition or disease Intervention/treatment Phase
Mitral Valve Insufficiency Device: TMVR Implant Not Applicable

Detailed Description:
The study is a prospective, multi-center, non-randomized trial to evaluate the safety and performance of the Twelve TMVR System in very high risk patients with severe, symptomatic mitral regurgitation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Performance of the Twelve Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
Actual Study Start Date : September 2014
Actual Primary Completion Date : April 2021
Actual Study Completion Date : April 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
TMVR Implant
 Device: TMVR Implant
Implantation of the Twelve TMVR System


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 30 days ]
    Number of patients with adverse events associated with the delivery and/or implantation of the device


Secondary Outcome Measures :
  1. Procedural Success [ Time Frame: Through 5 years ]
    Number of patients with successful TMVR implant

  2. Reduction of MR [ Time Frame: Through 5 years ]
    Number of patients with a reduction of MR Grade


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

Key Inclusion Criteria:

  • Severe mitral regurgitation (MR Grade 3-4+)
  • Symptomatic mitral regurgitation (NYHA Class II-IV)
  • Trans-apical access deemed feasible by the treating physician
  • Native mitral valve geometry and size compatible with the Twelve TMVR

Key Exclusion Criteria:

  • Left ventricular ejection fraction (LVEF) < 20
  • Evidence of intracardiac mass, thrombus, or vegetation
  • Prior valve surgery or need for other valve surgery
  • Prior stroke within 4 weeks
  • Need for coronary revascularization
  • History of, or active, endocarditis
  • Renal insufficiency (Creatinine > 2.5 mg/dL)
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): NCT02428010


Locations
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Poland
John Paul II Hospital
Krakow, Poland
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
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Study Director: Sonia Diaz de Leon Medtronic
More Information
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Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT02428010    
Other Study ID Numbers: CIP-1402
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases