Transapical Transcatheter Aortic Valve Implantation Clinical Trial
Official title:
A Prospective, Multicenter, Uncontrolled Study to Evaluate the Safety and Efficacy of the Cardiapex Percutaneous Trans-apical Access and Closure System
| NCT number | NCT01722591 |
| Other study ID # | CLN-PRO-01 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | November 2, 2012 |
| Last updated | February 3, 2015 |
| Start date | January 2013 |
| Verified date | February 2015 |
| Source | Cardiapex Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
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).
| Status | Terminated |
| Enrollment | 38 |
| Est. completion date | |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 70 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Germany | Kerckhoff Clinic | Bad Nauheim | |
| Germany | Hamburg University Heart Center | Hamburg |
| Lead Sponsor | Collaborator |
|---|---|
| Cardiapex Ltd. |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes | |
| Secondary | =30 day apical bleeding requiring surgical intervention | 30 days | Yes |