RecruitingNot ApplicableNCT04888247

HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve

HighLife TSMVR Feasibility Study of the Open Cell CLARITY Valve in Patients With Moderate-severe or Severe MR, High Surgical Risk and With a High Risk for Left Ventricular Outflow Tract Obstruction (LVOTO)

Sponsor

HighLife SAS

Enrollment

30 participants

Start Date

Jul 1, 2021

Study Type

INTERVENTIONAL

Conditions

Mitral Regurgitation

Summary

Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called CLARITY for people with mitral regurgitation. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECLARITY

Trans-septal mitral valve replacement

Locations(14)

Wesley Hospital

Auchenflower, Australia

Mount Hospital

Perth, Australia

Macquarie University Hospital

Sydney, Australia

AZ St. Jan - Brugge

Bruges, Belgium

UZ Leuven

Leuven, Belgium

CHU Lille

Lille, France

Centre Hospitalo - Univ de Nantes

Nantes, France

CHU de Rennes

Rennes, France

Cliniue Pasteur

Toulouse, France

Deutsches Herzzentrum Munchen

Munich, Germany

University Hospital Ulm

Ulm, Germany

Medical University of Silesia

Katowice, Poland

Medical University of Warsaw

Warsaw, Poland

Brighton and Sussex University Hospital

Brighton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04888247

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