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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 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.

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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.

Conditions Studied

Mitral Regurgitation

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

FieldValue
Enrollment Target 30 participants
Start Date 2020-07-14
Est. Completion 2030-12
Phase NA

Sponsor

HighLife SAS

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04029337

The ClinicalTrials.gov registry entry for NCT04029337 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,023-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (97% lower). The listed sponsor is HighLife SAS, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 10 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.