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NCT04029337 · ClinicalTrials.gov registry record · NA
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
A NA study of Mitral Regurgitation, sponsored by HighLife SAS.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 10
- Study locations
NCT04029337: Recruiting NA study of Mitral Regurgitation, sponsored by HighLife SAS.
NCT04029337 is a NA study of Mitral Regurgitation that is actively recruiting participants, run by HighLife SAS. The registered enrollment target is 30 participants, below the 1,023-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (97% lower). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04029337, a NA study of Mitral Regurgitation, is actively recruiting participants, sponsored by HighLife SAS.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 10
- Study locations
Study Summary
Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.
Primary Outcome
including: * All-cause mortality * Myocardial infarction or coronary ischemia requiring PCI or CABG * Major stroke * Life-threatening bleeding (MVARC scale) * Major access and vascular complications * Stage 2 or 3 acute kidney injury (includes dialysis) * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention * Severe hypotension, heart failure or respiratory failure requiring intravenous pressors or invasive or mechanical heart fail
Conditions Studied
Interventions
- DEVICE Transcatheter Mitral Valve Replacement
Study Locations (10)
Arizona
- Tucson Medical Center - Tucson
California
- Los Robles Regional Medical Center - Los Angeles
Georgia
- Piedmont Heart - Atlanta
Massachusetts
- Brigham and Women's Hospital - Boston
Minnesota
- Minneapolis Heart - Minneapolis
New York
- Montefiore Medical Center - New York
Pennsylvania
- University of Pennsylvania - Philadelphia
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-07-14 |
| Est. Completion | 2030-12 |
| Phase | NA |
What NCT04029337 shows while recruiting
NCT04029337 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,023-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Mitral Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which Transcatheter Mitral Valve Replacement is the first listed.
NCT04029337 lists 10 locations in 10 states (Arizona, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT04029337 about?
NCT04029337 is a clinical study titled "An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System". Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.
What is the current status of trial NCT04029337?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2020-07-14. Estimated completion is 2030-12.
What conditions does trial NCT04029337 study?
This clinical trial studies the following conditions: Mitral Regurgitation.
What interventions are being tested in trial NCT04029337?
The interventions under investigation include: Transcatheter Mitral Valve Replacement (DEVICE).
Who is sponsoring clinical trial NCT04029337?
This trial is sponsored by HighLife SAS, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04029337 being conducted?
This trial has 10 study locations across Arizona, California, Georgia, Massachusetts, 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 NCT04029337's enrollment target sits among peer trials
30 22nd of 26 higher than 5 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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The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
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-
Cephea Early Feasibility Study
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-
The CardioClip Study
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