Aortic Stenosis Clinical Trial
Official title:
CardioCel Tri-leaflet Repair Study; a Prospective, Non-randomised, Single Arm, Multi-centre Clinical Investigation
This study will quantify the safety and efficacy of the CardioCel implant in tri-leaflet repair. 80 patients in up to 7 sites in Europe and the US will all be treated with the CardioCel implant.
The purpose of this study is to evaluate the safety and efficacy of the CardioCel for the
repair of aortic valve stenosis and/or insufficiency. CardioCel is a cardiovascular patch
manufactured with the so called ADAPT® technology. The ADAPT technology uses bovine
spongiform encephalopathy-free pericardium which is processed in several ways to make it
biocompatible with human tissue. CardioCel should provide an off the shelf material solution
for tri-leaflet repair surgery due to its functional attributes, low propensity for post
implant calcification, and overall biocompatibility. As a result adverse events and
complications associated with the autologous pericardium repair surgery are mitigated.
In this study patients suffering from moderate-to-severe aortic stenosis and/or aortic
insufficiency will be included.
In this study 80 patients will be enrolled in up to 7 centers in Europe and the US. The
expected study duration is 36 months; 12 months of recruitment and 24 months follow-up.
CardioCel is US FDA cleared for the repair of cardiac and vascular defects, including
intra-cardiac defects; septal defects, valve and annulus repair, great vessel reconstruction,
peripheral vascular reconstruction, suture line buttressing and pericardial closure.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04310046 -
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
|
N/A | |
| Recruiting |
NCT06008080 -
Post-Market Clinical Follow Up Study With Navitor Valve
|
||
| Recruiting |
NCT06055751 -
Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
|
||
| Active, not recruiting |
NCT04815785 -
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
|
N/A | |
| Terminated |
NCT02202434 -
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
|
N/A | |
| Recruiting |
NCT03029026 -
The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
|
||
| Active, not recruiting |
NCT02903420 -
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
|
N/A | |
| Completed |
NCT02306226 -
Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
|
||
| Withdrawn |
NCT01648309 -
Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation
|
N/A | |
| Completed |
NCT01676727 -
ADVANCE Direct Aortic Study
|
||
| Completed |
NCT01422044 -
Risk Prediction in Aortic Stenosis
|
N/A | |
| Withdrawn |
NCT00774657 -
Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography
|
N/A | |
| Terminated |
NCT00535899 -
Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS)
|
N/A | |
| Terminated |
NCT05070130 -
OpSens PRIME CLASS
|
||
| Completed |
NCT03314857 -
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
|
N/A | |
| Completed |
NCT04157920 -
Impact of Predilatation Between Self-expanding Valves
|
N/A | |
| Enrolling by invitation |
NCT06212050 -
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
|
||
| Recruiting |
NCT05893082 -
Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
|
N/A | |
| Completed |
NCT03250806 -
Early Detection of Aortic Stenosis in the Community During Flu Vaccination
|
||
| Enrolling by invitation |
NCT04031274 -
Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry
|