Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study

April 29, 2021 updated by: Medtronic Cardiovascular

Evaluation of Safety and Performance of the Twelve Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation

Study to evaluate the safety and performance of the Twelve TMVR System

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Krakow, Poland
        • John Paul II Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment
TMVR Implant
Device: TMVR Implant
Implantation of the Twelve TMVR System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 30 days
Number of patients with adverse events associated with the delivery and/or implantation of the device
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural Success
Time Frame: Through 5 years
Number of patients with successful TMVR implant
Through 5 years
Reduction of MR
Time Frame: Through 5 years
Number of patients with a reduction of MR Grade
Through 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Investigators

  • Study Director: Sonia Diaz de Leon, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2014

Primary Completion (ACTUAL)

April 1, 2021

Study Completion (ACTUAL)

April 1, 2021

Study Registration Dates

First Submitted

April 23, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (ESTIMATE)

April 28, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-1402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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