Brief Title
CardioCel Tri-leaflet Repair Study
Official Title
CardioCel Tri-leaflet Repair Study; a Prospective, Non-randomised, Single Arm, Multi-centre Clinical Investigation
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.
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
Interventional
Primary Outcome
In-hospital survival (defined as percentage of patients alive and discharged from the index operation - presented as the inverse, or standard surgical operative mortality)
Secondary Outcome
Changes from preoperative to 6-months postoperative in linear left ventricular (LV) diastolic and systolic dimensions measured from parasternal long axis views by echocardiography.
Condition
Aortic Stenosis
Intervention
CardioCel
Study Arms / Comparison Groups
CardioCel
Description: Treatment with CardioCel implant
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
28
Start Date
September 2015
Completion Date
November 19, 2018
Primary Completion Date
July 5, 2017
Eligibility Criteria
Inclusion Criteria:
1. 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.
2. The subject is suitable for a tri-leaflet repair.
3. The subject has documented moderate-to-severe AS and/or AI.
4. 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.
5. The subject upon final intraoperative assessment has intracardiac anatomy suitable for
tri-leaflet repair using CardioCel.
Exclusion Criteria:
1. Greater than 85 years of age at the time of consent.
2. The subject's annular measurements < 19 mm or > 27mm.
3. All patients will be excluded who require emergent surgery (within 24 hours of a
presentation to an emergency department) for any reason.
4. The subject will be excluded with pre-existing valve prosthesis in the aortic
position.
5. Patients requiring repair of other cardiac valves will be excluded.
6. The subject has active endocarditis.
7. Heavily calcified aortic roots or "porcelain aortas" (as evidenced on cardiac echo).
8. Leukopenia with a WBC of less than 3000 cells per microliter.
9. Acute anaemia with a haemoglobin less than 8 g/dL.
10. Platelet count less than 150.000 platelets/microliter.
11. History of a defined bleeding diathesis or coagulopathy or the subject refuses blood
transfusions.
12. Active infection requiring antibiotic therapy (if temporary illness, subjects may
enrol 2-4 weeks after discontinuation of antibiotics).
13. Subjects in whom trans oesophageal echocardiography (TEE) is contraindicated.
14. Low Ejection Fraction (EF) < 35%.
15. Life expectancy < 1 year, or severe comorbidities, such as cancer, dialysis, or severe
COPD at the investigator's discretion
16. The subject is an illicit drug user, alcohol abuser, prisoner, institutionalised, or
is unable to give informed consent.
17. The subject is pregnant or lactating (non-pregnancy to be confirmed by pregnancy test
for all child bearing potential females prior to enrolment).
18. Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack
(TIA).
19. Myocardial Infarction (MI) within one month of trial inclusion
20. Upon intraoperative assessment of the intracardiac anatomy the patient is not suitable
for tri-leaflet repair using CardioCel.
Gender
All
Ages
N/A - 85 Years
Accepts Healthy Volunteers
No
Contacts
Dominico Mazzitelli, M.D., ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT02629328
Organization ID
CTRS-2015-01
Secondary IDs
EUDAMED
Responsible Party
Sponsor
Study Sponsor
Admedus Regen Pty Ltd.
Study Sponsor
Dominico Mazzitelli, M.D., Principal Investigator, German Heart Centre of the Technical University
Verification Date
January 2019