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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. Identifier: NCT02428010
Recruitment Status : Active, not recruiting
First Posted : April 28, 2015
Last Update Posted : October 22, 2020
Information provided by (Responsible Party):
Medtronic Cardiovascular

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Treatment
TMVR Implant
Device: TMVR Implant
Implantation of the Twelve TMVR System

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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 identifier (NCT number): NCT02428010

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John Paul II Hospital
Krakow, Poland
Sponsors and Collaborators
Medtronic Cardiovascular
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Study Director: Sonia Diaz de Leon Medtronic
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Responsible Party: Medtronic Cardiovascular Identifier: NCT02428010    
Other Study ID Numbers: CIP-1402
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases