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

A Prospective, Multicenter, Uncontrolled Study to Evaluate the Safety and Efficacy of the Cardiapex Percutaneous Trans-apical Access and Closure System

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).

Study Overview

• Status: Terminated
• Conditions: Transapical Transcatheter Aortic Valve Implantation
• Intervention / Treatment: Device: Cardiapex device

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Nauheim, Germany
    • Kerckhoff Clinic
  • Hamburg, Germany
    • Hamburg University Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiapex device; Use of the Cardiapex device in the context of transapical TAVI procedures	Device: Cardiapex device; Cardiapex percutaneous transapical access and closure system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
≤30 day apical bleeding requiring surgical intervention	30 days

Collaborators and Investigators

• Sponsor: Cardiapex Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: November 2, 2012
• First Submitted That Met QC Criteria: November 5, 2012
• First Posted (Estimate): November 7, 2012

Study Record Updates

• Last Update Posted (Estimate): February 4, 2015
• Last Update Submitted That Met QC Criteria: February 3, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CLN-PRO-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No