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

Not Applicable

Terminated

• Conditions: Transapical Transcatheter Aortic Valve Implantation
• Interventions: Device: Cardiapex device

• Registration Number: NCT01722591
• Lead Sponsor: Cardiapex Ltd.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-02
• Study First Submitted QC: 2012-11-05
• Study First Posted: 2012-11-07
• Study Start: 2013-01
• Primary Completion: 2014-02
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-03
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiapex device	Cardiapex device	Use of the Cardiapex device in the context of transapical TAVI procedures

Primary Outcome Measures

Name	Time	Method
Successful performance of percutaneous transapical TAVI defined as: "Successful percutaneous transapical access and deployment of a single prosthetic heart valve"	Outcome measure assessed during the TAVI surgical procedure - an average of 3 hours

Secondary Outcome Measures

Name	Time	Method
≤30 day apical bleeding requiring surgical intervention	30 days

Trial Locations

Locations (2)

Kerckhoff Clinic; 🇩🇪 Bad Nauheim, Germany

Hamburg University Heart Center; 🇩🇪 Hamburg, Germany