- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02629328
CardioCel Tri-leaflet Repair Study (CTRS)
CardioCel Tri-leaflet Repair Study; a Prospective, Non-randomised, Single Arm, Multi-centre Clinical Investigation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Leuven, Belgium, 3000
- Universtiy Hospital Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: CardioCel
Treatment with CardioCel implant
|
Treatment with CardioCel implant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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)
Time Frame: Pre-operative to 14 days post-operative
|
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
|
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
|
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
|
Up to 12 months post-valve repair
|
Secondary Outcome Measures
Outcome Measure |
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.
Time Frame: Pre-operative to 6 months post-valve repair
|
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
|
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
|
Pre-operative to 6 months post-valve repair
|
Changes in symptomatic status (NYHA CHF Classification) from preoperative to 6 months after aortic valve repair.
Time Frame: Pre-operative to 6 months post-valve repair
|
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
|
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
|
From study enrolment to 24 months post-valve repair
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dominico Mazzitelli, M.D., German Heart Centre of the Technical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTRS-2015-01
- EUDAMED (Other Identifier: CIV-15-07-013706)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aortic Stenosis
-
Hospices Civils de LyonRecruiting
-
Abbott Medical DevicesActive, not recruitingSevere Aortic Stenosis | Symptomatic Degenerative Aortic StenosisSpain, Italy, United Kingdom, Germany, Switzerland, Czechia, Australia, Belgium, Poland
-
Edwards LifesciencesActive, not recruitingAortic Stenosis | Aortic Regurgitation | Symptomatic Aortic StenosisChina
-
Anteris Technologies Ltd.Active, not recruitingAortic Valve Calcification | Severe Aortic Valve Stenosis | Symptomatic Aortic StenosisGeorgia
-
Anteris Technologies Ltd.Active, not recruitingAortic Stenosis | Aortic Valve Calcification | Severe Aortic Valve Stenosis | Symptomatic Aortic StenosisUnited States
-
Edwards LifesciencesCompletedAortic Stenosis | Aortic Regurgitation | Symptomatic Aortic StenosisChina
-
Ningbo Jenscare Biotechnology Co., Ltd.UnknownAortic Regurgitation | Severe Aortic Stenosis
-
Genesis Medtech CorporationRecruitingDiseases of Aortic Valve | Aortic Stenosis DiseaseChina
-
Saint Petersburg State University, RussiaNot yet recruitingIschemic Heart Disease | Mitral Insufficiency | Aortic Stenosis, Severe | Mitral Stenosis | Aortic Insufficiency | Ascending Aortic Aneurysm | Mitral Stenosis With Insufficiency | Tricuspid InsufficiencyRussian Federation
-
Pan XiangbinRecruiting
Clinical Trials on CardioCel
-
LeMaitre VascularFactory CRO for Medical Devices B.V.RecruitingIntracardiac and Septal Defects | Valve and Anulus Repair | Great Vessel Reconstruction | Peripheral Vessel Reconstruction | Suture Line ButtressingGermany, Italy, Spain, United Kingdom