Back to resultsTwelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study
Primary Purpose
Mitral Valve Insufficiency
Status
Terminated
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
TMVR Implant
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Valve Insufficiency
Eligibility 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)
Sites / Locations
- John Paul II Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
TMVR Implant
Outcomes
Primary Outcome Measures
Adverse Events
Number of patients with adverse events associated with the delivery and/or implantation of the device
Secondary Outcome Measures
Procedural Success
Number of patients with successful TMVR implant
Reduction of MR
Number of patients with a reduction of MR Grade
Full Information
NCT ID
NCT02428010
First Posted
April 23, 2015
Last Updated
April 29, 2021
Sponsor
Medtronic Cardiovascular
1. Study Identification
Unique Protocol Identification Number
NCT02428010
Brief Title
Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study
Official Title
Evaluation of Safety and Performance of the Twelve Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
September 2014 (Actual)
Primary Completion Date
April 2021 (Actual)
Study Completion Date
April 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study to evaluate the safety and performance of the Twelve TMVR System
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
TMVR Implant
Intervention Type
Device
Intervention Name(s)
TMVR Implant
Intervention Description
Implantation of the Twelve TMVR System
Primary Outcome Measure Information:
Title
Adverse Events
Description
Number of patients with adverse events associated with the delivery and/or implantation of the device
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Procedural Success
Description
Number of patients with successful TMVR implant
Time Frame
Through 5 years
Title
Reduction of MR
Description
Number of patients with a reduction of MR Grade
Time Frame
Through 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Diaz de Leon
Organizational Affiliation
Medtronic
Official's Role
Study Director
Facility Information:
Facility Name
John Paul II Hospital
City
Krakow
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study
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