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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Treatment with CardioCel implant
Universtiy Hospital Leuven
Leuven, Belgium
In-hospital survival (defined as percentage of patients alive and discharged from the index operation - presented as the inverse, or standard surgical operative mortality)
Time frame: Pre-operative to 14 days post-operative
Changes in mean aortic valve gradients from preoperative (baseline screening) to 6 months post-valve repair assessed by transthoracic or transesophageal echocardiography
Time frame: Pre-operative to 6 months post-valve repair
Mean transaortic valve gradient, measured using echocardiography, postoperatively, and at 6 and 12 months after valve repair.
Time frame: Up to 12 months post-valve repair
Aortic regurgitation grade (assessed on a 0-4 scale), measured using echocardiography, postoperatively, and at 6 and 12 months after valve repair.
Time frame: Up to 12 months post-valve repair
Changes from preoperative to 6-months postoperative in linear left ventricular (LV) diastolic and systolic dimensions measured from parasternal long axis views by echocardiography.
Time frame: Pre-operative to 6 months post-valve repair
Changes from preoperative to 6-months postoperative in left ventricular volume measured by the Simpson's Biplane method using echocardiography.
Time frame: Pre-operative to 6 months post-valve repair
Changes from preoperative to 6-months postoperative in LV mass (if calculated), using the area-length method, assessed by echocardiography.
Time frame: Pre-operative to 6 months post-valve repair
Changes in symptomatic status (NYHA CHF Classification) from preoperative to 6 months after aortic valve repair.
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Time frame: Pre-operative to 6 months post-valve repair
Changes in patient reported outcomes (EQ-5D) from baseline to 26 week postoperative
Time frame: Baseline to 26 weeks post-valve repair
Implant procedure success (evaluated through post-procedure hospital discharge) measured by the incidence of pre-defined adverse events:
Time frame: From study enrolment to 24 months post-valve repair