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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01722591

Enrollment

Registered

2012-11-07

Start date

2013-01-31

Completion date

Unknown

Last updated

2015-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transapical Transcatheter Aortic Valve Implantation

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).

Interventions

DEVICECardiapex device

Cardiapex percutaneous transapical access and closure system

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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

Design outcomes

Primary

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

Measure	Time frame
≤30 day apical bleeding requiring surgical intervention	30 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026