Status:
COMPLETED
Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)
Lead Sponsor:
Germans Trias i Pujol Hospital
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this trial is to evaluate safety and efficacy of a pericardial adipose pedicle transposition (adiFLAP) for the improvement of cardiac function in patients with a chronic myocardial infa...
Detailed Description
This novel intervention consists of the pericardial isolation of adipose tissue maintaining its vascularization to create an adipose flap (adiFLAP) and its transposition fully covering infarcted myoca...
Eligibility Criteria
Inclusion
- Established transmural myocardial infarction non candidate to revascularization (\>3 months-old)
- Candidate to coronary by-pass for other territories different from the previous transmural infarct.
- \> 18 years of age, male or female, capable of giving an informed consent.
Exclusion
- Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
- Severe valvular disease candidate for surgical restoration.
- Candidate to ventricular remodeling.
- Contraindication for NMR (creatinin clearance \<30 ml/min/1.73m2, metallic implants, claustrophobia).
- Severe renal or hepatic failure.
- Abnormal laboratory tests (no explanation at the time of inclusion).
- Previous cardiac intervention.
- High surgical risk (Euroscore 2).
- Pregnant or breast feeding women.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01473433
Start Date
January 1 2012
End Date
December 1 2014
Last Update
July 24 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Germans Trias Research Institute; Germans Trias University Hospital
Badalona, Barcelona, Spain, 08916