A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)

Edwards Lifesciences2 enrolled

Overview

The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System. The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mitral Insufficiency Heart Valve Disease Cardiovascular Disease Heart Disease

Interventions

CardiAQ TMVI System (Transapical DS)DEVICE

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * NYHA Classification ≥ III * Left Ventricular Ejection Fraction ≥ 30% * Mitral regurgitation ≥ Grade 3+ * Subject meets anatomical eligibility criteria for the investigational device

Locations (9)

Rigshospitalet University Hospital

Copenhagen, Denmark

Centre hospitalier régional universitaire de Lille

Lille, France

Hôpital Européen Georges-Pompidou

Paris, France

Centre Hospitalier Universiatier de Toulouse

Toulouse, France

Outcomes

Primary Outcomes

Composite Major Adverse Event Rate

Time frame: 30-Day

Composite Major Adverse Event Rate

Time frame: 12-Month

Data from ClinicalTrials.gov

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