CardioCel Tri-leaflet Repair Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CardioCel Tri-leaflet Repair Study; a Prospective, Non-randomised, Single Arm, Multi-centre Clinical Investigation

Conditions
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Aortic Stenosis, Aortic Insufficiency

Intervention / Treatment
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* Device: CardioCel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject's annular measurements are ≥ 19 mm to < 27mm as confirmed on pre-op echo and inter commissure distance equal to or bigger than 19mm as confirmed intraoperatively. The subject is suitable for a tri-leaflet repair. The subject has documented moderate-to-severe AS and/or AI. The subject is willing and able to comply with specified follow-up evaluations, including trans oesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve. The subject has reviewed and signed the written informed consent form. The subject upon final intraoperative assessment has intracardiac anatomy suitable for tri-leaflet repair using CardioCel. Exclusion Criteria: Greater than 85 years of age at the time of consent. The subject's annular measurements < 19 mm or > 27mm. All patients will be excluded who require emergent surgery (within 24 hours of a presentation to an emergency department) for any reason. The subject will be excluded with pre-existing valve prosthesis in the aortic position. Patients requiring repair of other cardiac valves will be excluded. The subject has active endocarditis. Heavily calcified aortic roots or porcelain aortas (as evidenced on cardiac echo). Leukopenia with a WBC of less than 3000 cells per microliter. Acute anaemia with a haemoglobin less than 8 g/dL. Platelet count less than 150.000 platelets/microliter. History of a defined bleeding diathesis or coagulopathy or the subject refuses blood transfusions. Active infection requiring antibiotic therapy (if temporary illness, subjects may enrol 2-4 weeks after discontinuation of antibiotics). Subjects in whom trans oesophageal echocardiography (TEE) is contraindicated. Low Ejection Fraction (EF) < 35%. Life expectancy < 1 year, or severe comorbidities, such as cancer, dialysis, or severe COPD at the investigator's discretion The subject is an illicit drug user, alcohol abuser, prisoner, institutionalised, or is unable to give informed consent. The subject is pregnant or lactating (non-pregnancy to be confirmed by pregnancy test for all child bearing potential females prior to enrolment). Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA). Myocardial Infarction (MI) within one month of trial inclusion Upon intraoperative assessment of the intracardiac anatomy the patient is not suitable for tri-leaflet repair using CardioCel.

Ages Eligible for Study
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Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CardioCel<br>Treatment with CardioCel implant | Device: CardioCel<br>* Treatment with CardioCel implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital survival (defined as percentage of patients alive and discharged from the index operation - presented as the inverse, or standard surgical operative mortality) |  | 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 |  | 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. |  | 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. |  | Up to 12 months post-valve repair | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from preoperative to 6-months postoperative in linear left ventricular (LV) diastolic and systolic dimensions measured from parasternal long axis views by echocardiography. |  | 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. |  | 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. |  | Pre-operative to 6 months post-valve repair | 
| Changes in symptomatic status (NYHA CHF Classification) from preoperative to 6 months after aortic valve repair. |  | Pre-operative to 6 months post-valve repair | 
| Changes in patient reported outcomes (EQ-5D) from baseline to 26 week postoperative |  | 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: |  | From study enrolment to 24 months post-valve repair | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CardioCel, FDA cleared, Tri-leaflet repair, Aortic valves