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NCT04375332 · ClinicalTrials.gov registry record · NA
Beating Heart Mitral Valve Repair With the HARPOON™ System
A NA study of Mitral Regurgitation, sponsored by Edwards Lifesciences.
- Active
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 9
- Study locations
NCT04375332: Active NA study of Mitral Regurgitation, sponsored by Edwards Lifesciences.
NCT04375332 is a NA study of Mitral Regurgitation that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 25 participants, below the 1,023-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (98% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04375332, a NA study of Mitral Regurgitation, is active but no longer recruiting, sponsored by Edwards Lifesciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 9
- Study locations
Study Summary
The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).
Primary Outcome
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV.
Conditions Studied
Interventions
- DEVICE HARPOON™ Beating Heart Mitral Valve Repair System
Study Locations (9)
Maryland
- University of Maryland Medical Center - Baltimore
- Johns Hopkins - Baltimore
California
- UCSF - San Francisco
Georgia
- Piedmont Heart Institute - Atlanta
Michigan
- University of Michigan Health System - Ann Arbor
Minnesota
- Mayo Clinic - Rochester
Oregon
- OHSU Knight Cardiovascular Institute - Portland
Tennessee
- Centennial Medical Center - Nashville
Utah
- Intermountain Heart Institute - Murray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-12-16 |
| Est. Completion | 2027-12-20 |
| Phase | NA |
What the registry record for NCT04375332 still lists
NCT04375332 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,023-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Mitral Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which HARPOON™ Beating Heart Mitral Valve Repair System is the first listed.
NCT04375332 lists 9 locations in 8 states (Maryland, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT04375332 about?
NCT04375332 is a clinical study titled "Beating Heart Mitral Valve Repair With the HARPOON™ System". The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).
What is the current status of trial NCT04375332?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2020-12-16. Estimated completion is 2027-12-20.
What conditions does trial NCT04375332 study?
This clinical trial studies the following conditions: Mitral Regurgitation.
What interventions are being tested in trial NCT04375332?
The interventions under investigation include: HARPOON™ Beating Heart Mitral Valve Repair System (DEVICE).
Who is sponsoring clinical trial NCT04375332?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04375332 being conducted?
This trial has 9 study locations across California, Georgia, Maryland, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mitral 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 NCT04375332's enrollment target sits among peer trials
25 23rd of 26 higher than 2 of 26 other Mitral Regurgitation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mitral 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
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An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
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The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
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Cephea Early Feasibility Study
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-
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