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NCT02322840 · ClinicalTrials.gov registry record · NA
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
A NA study of Mitral Valve Insufficiency, sponsored by Medtronic Cardiovascular.
- Active
- Registry status
- NA
- Development phase
- 128
- Enrollment target
- 20
- Study locations
NCT02322840: Active NA study of Mitral Valve Insufficiency, sponsored by Medtronic Cardiovascular.
NCT02322840 is a NA study of Mitral Valve Insufficiency that is active but no longer recruiting, run by Medtronic Cardiovascular. The registered enrollment target is 128 participants, below the 375-participant average among 11 other Mitral Valve Insufficiency trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02322840, a NA study of Mitral Valve Insufficiency, is active but no longer recruiting, sponsored by Medtronic Cardiovascular.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 128 participants
- Enrollment target
- 20
- Study locations
Study Summary
PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients. EFS: The study is an Early Feasibility Study to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with moderate-Severe or severe, Symptomatic Mitral Regurgitation
Primary Outcome
PILOT: Site Reported Serious Adverse Events Implant or Delivery Related Through 30-Days EFS: Implant, Delivery or device related serious adverse events through 30 days post procedure
Conditions Studied
Interventions
- DEVICE Twelve TMVR Implant
- DEVICE Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
Study Locations (20)
New York
- NYU Langone Medical Center - PILOT - New York
- The Mount Sinai Hospital (New York NY) - EFS - New York
- The Mount Sinai Hospital (New York NY) - PILOT - New York
- New York-Presbyterian Hospital Columbia University Medical Center - EFS - New York
- New York-Presbyterian Hospital Columbia University Medical Center - PILOT - New York
Michigan
- University of Michigan Health System - University Hospital - PILOT - Ann Arbor
- Corewell Health - EFS - Grand Rapids
Minnesota
- Abbott Northwestern Hospital - EFS - Minneapolis
- Abbott Northwestern Hospital - PILOT - Minneapolis
Texas
- Baylor Jack and Jane Hamilton Heart and Vascular Hospital - PILOT - Dallas
- Houston Methodist Hospital - PILOT - Houston
Arizona
- Abrazo Arizona Heart Hospital - EFS - Phoenix
California
- Cedars-Sinai Medical Center - PILOT - Los Angeles
Georgia
- Piedmont Atlanta Hospital - PILOT - Atlanta
Illinois
- Northwestern Memorial Hospital - PILOT - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2015-04 |
| Est. Completion | 2028-12 |
| Phase | NA |
What the registry record for NCT02322840 still lists
NCT02322840 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 375-participant average among 11 other Mitral Valve Insufficiency trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Mitral Valve Insufficiency appearing as the primary indexed condition, and to 2 interventions - of which Twelve TMVR Implant is the first listed.
NCT02322840 names 20 study sites across 13 states, led by New York, Michigan, Minnesota.
Frequently Asked Questions
What is clinical trial NCT02322840 about?
NCT02322840 is a clinical study titled "Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System". PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients. EFS: The study is an Early Feasibility Study to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement Syst...
What is the current status of trial NCT02322840?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 128 participants. The study started on 2015-04. Estimated completion is 2028-12.
What conditions does trial NCT02322840 study?
This clinical trial studies the following conditions: Mitral Valve Insufficiency.
What interventions are being tested in trial NCT02322840?
The interventions under investigation include: Twelve TMVR Implant (DEVICE), Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System (DEVICE).
Who is sponsoring clinical trial NCT02322840?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02322840 being conducted?
This trial has 20 study locations across Arizona, California, Georgia, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02322840's enrollment target sits among peer trials
128 9th of 11 higher than 3 of 11 other Mitral Valve Insufficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mitral Valve Insufficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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