CTRS: CardioCel Tri-leaflet Repair Study
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: CardioCel Treatment with CardioCel implant |
Device: CardioCel
Treatment with CardioCel implant
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Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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The subject is suitable for a tri-leaflet repair.
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The subject has documented moderate-to-severe AS and/or AI.
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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.
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The subject upon final intraoperative assessment has intracardiac anatomy suitable for tri-leaflet repair using CardioCel.
Exclusion Criteria:
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Greater than 85 years of age at the time of consent.
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The subject's annular measurements < 19 mm or > 27mm.
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All patients will be excluded who require emergent surgery (within 24 hours of a presentation to an emergency department) for any reason.
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The subject will be excluded with pre-existing valve prosthesis in the aortic position.
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Patients requiring repair of other cardiac valves will be excluded.
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The subject has active endocarditis.
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Heavily calcified aortic roots or "porcelain aortas" (as evidenced on cardiac echo).
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Leukopenia with a WBC of less than 3000 cells per microliter.
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Acute anaemia with a haemoglobin less than 8 g/dL.
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Platelet count less than 150.000 platelets/microliter.
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History of a defined bleeding diathesis or coagulopathy or the subject refuses blood transfusions.
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Active infection requiring antibiotic therapy (if temporary illness, subjects may enrol 2-4 weeks after discontinuation of antibiotics).
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Subjects in whom trans oesophageal echocardiography (TEE) is contraindicated.
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Low Ejection Fraction (EF) < 35%.
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Life expectancy < 1 year, or severe comorbidities, such as cancer, dialysis, or severe COPD at the investigator's discretion
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The subject is an illicit drug user, alcohol abuser, prisoner, institutionalised, or is unable to give informed consent.
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The subject is pregnant or lactating (non-pregnancy to be confirmed by pregnancy test for all child bearing potential females prior to enrolment).
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Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
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Myocardial Infarction (MI) within one month of trial inclusion
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Upon intraoperative assessment of the intracardiac anatomy the patient is not suitable for tri-leaflet repair using CardioCel.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Universtiy Hospital Leuven | Leuven | Belgium | 3000 |
Sponsors and Collaborators
- Admedus Regen Pty Ltd.
Investigators
- Principal Investigator: Dominico Mazzitelli, M.D., German Heart Centre of the Technical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTRS-2015-01
- EUDAMED