Safety and Efficacy Study of the Cardiapex Percutaneous Trans-apical Access and Closure System

Cardiapex

Status: Terminated

Conditions: Transapical Transcatheter Aortic Valve Implantation

Treatments: Device: Cardiapex device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01722591

CLN-PRO-01

Details and patient eligibility

About

A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended for percutaneous access and closure of the left ventricular apex in conjunction with transapical Transcatheter Aortic Valve Implantation (TAVI).

Enrollment: 38 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient scheduled for transapical TAVI
• Patient ≥ 70 years of age
• Patient able to give informed written consent
• Patient able to attend follow up examinations

Exclusion criteria

• Scheduled concomitant non-TAVI cardiac procedure
• Patient with Left Ventricular Ejection Fraction (LVEF) < 30% at time of enrollment
• Patient with known apical infarcted area
• Patient with a distinct large vessel right at the anatomical apex9 (based on pre-operative coronary angiography
• Patients with known lung tissue surrounding the apex and possibly interfering with the in-out puncture (based on preoperative gated CT assessment
• Patient with contra-indications to transapical TAVI
• Patient's inability to tolerate or comply with normal post-surgical drug regimen
• Patient's inability to comply with required follow-ups, including echocardiography
• Patient participation in other clinical trials within previous month

Trial design

38 participants in 1 patient group

Cardiapex device

Experimental group

Description:

Use of the Cardiapex device in the context of transapical TAVI procedures

Treatment:

Device: Cardiapex device