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

Edwards Lifesciences

Status: Terminated

Conditions: Mitral Insufficiency; Heart Disease; Heart Valve Disease; Cardiovascular Disease

Treatments: Device: CardiAQ TMVI System (Transapical DS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02478008

CIP-3102-01

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

CardiAQ TMVI System (Transapical DS)

Experimental group

Treatment:

Device: CardiAQ TMVI System (Transapical DS)