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NCT04198870 · ClinicalTrials.gov registry record · NA
MitraClip REPAIR MR Study
A NA study of Mitral Valve Regurgitation, sponsored by Abbott Medical Devices.
- Active
- Registry status
- NA
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT04198870: Active NA study of Mitral Valve Regurgitation, sponsored by Abbott Medical Devices.
NCT04198870 is a NA study of Mitral Valve Regurgitation that is active but no longer recruiting, run by Abbott Medical Devices. The registered enrollment target is 500 participants, below the 769-participant average among 11 other Mitral Valve Regurgitation trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04198870, a NA study of Mitral Valve Regurgitation, is active but no longer recruiting, sponsored by Abbott Medical Devices.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.
Primary Outcome
The proportion of subjects who are alive, without stroke, CV hospitalization or acute kidney injury requiring renal replacement therapy at 2 years in the Device and Control groups, respectively
Conditions Studied
Interventions
- DEVICE MitraClip™ device implantation
- PROCEDURE Mitral Valve Repair Surgery
Study Locations (20)
California
- Scripps Health - La Jolla
- Sutter Medical Center, Sacramento - Sacramento
- University of California - Davis Medical Center - Sacramento
- Mercy General Hospital - Sacramento
- University of California at San Francisco - San Francisco
- Stanford University Medical Center - Stanford
- Los Robles Regional Medical Center - Thousand Oaks
Arizona
- Banner-University Medical Center Phoenix - Phoenix
- St. Josephs Hospital and Medical Center - Phoenix
- Arizona Cardiovascular Research Center - Phoenix
- Tucson Medical Center - Tucson
Alabama
- University Hospital - Univ. of Alabama at Birmingham (UAB) - Birmingham
- Cardiology Associates of Mobile, Inc. - Mobile
Florida
- Baptist Medical Center - Jacksonville
- NCH Healthcare System - Naples
Illinois
- Northwestern Memorial Hospital - Chicago
- Prairie Education & Research Cooperative - Springfield
Colorado
- Saint Joseph Hospital - Denver
Connecticut
- Yale New Haven Hospital - New Haven
Georgia
- Piedmont Heart Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2020-07-21 |
| Est. Completion | 2035-12 |
| Phase | NA |
What the registry record for NCT04198870 still lists
NCT04198870 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 769-participant average among 11 other Mitral Valve Regurgitation trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Mitral Valve Regurgitation appearing as the primary indexed condition, and to 2 interventions - of which MitraClip™ device implantation is the first listed.
NCT04198870 names 20 study sites across 8 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT04198870 about?
NCT04198870 is a clinical study titled "MitraClip REPAIR MR Study". The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by...
What is the current status of trial NCT04198870?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2020-07-21. Estimated completion is 2035-12.
What conditions does trial NCT04198870 study?
This clinical trial studies the following conditions: Mitral Valve Regurgitation.
What interventions are being tested in trial NCT04198870?
The interventions under investigation include: MitraClip™ device implantation (DEVICE), Mitral Valve Repair Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT04198870?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04198870 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mitral Valve Regurgitation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04198870's enrollment target sits among peer trials
500 5th of 11 higher than 7 of 11 other Mitral Valve Regurgitation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mitral Valve Regurgitation 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
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-
AltaValve Pivotal Trial
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-
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
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-
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
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-
PARTNER 3 Trial - Mitral Valve in Valve
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-
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR
COMPLETED · NA
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