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Recruiting Not applicable Interventional

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

ClinicalTrials.gov ID: NCT04029337

Public ClinicalTrials.gov record NCT04029337. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 20, 2026, 6:21 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Study identification

NCT ID
NCT04029337
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
HighLife SAS
Industry
Enrollment
30 participants

Conditions and interventions

Interventions

  • Transcatheter Mitral Valve Replacement Device

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 13, 2020
Primary completion
Nov 30, 2025
Completion
Nov 30, 2030
Last update posted
Mar 16, 2025

2020 – 2030

United States locations

U.S. sites
10
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
Tucson Medical Center Tucson Arizona 85712 Recruiting
Los Robles Regional Medical Center Los Angeles California 91360 Recruiting
Piedmont Heart Atlanta Georgia 30309 Recruiting
Brigham and Women's Hospital Boston Massachusetts 02115 Recruiting
Minneapolis Heart Minneapolis Minnesota 55407 Recruiting
Montefiore Medical Center New York New York 10467 Recruiting
University of Pennsylvania Philadelphia Pennsylvania 19104 Terminated
Medical University of South Carolina Charleston South Carolina 29425 Recruiting
Houston Methodist Hospital Houston Texas 77030 Recruiting
Chippenham Hospital Richmond Richmond Virginia 23225 Terminated

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04029337, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 16, 2025 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04029337 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →