Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial
Antoni Bayés Genís
70 participants
Mar 1, 2017
INTERVENTIONAL
Conditions
Summary
The purpose of this trial is to evaluate the efficacy of a pericardial adipose graft transposition (Adipose Graft Trasposition Procedure, AGTP) for the improvement of cardiac function in patients with a chronic myocardial infarction. Preclinical studies in the porcine model of myocardial infarction have shown that the AGTP reduces infarct area and improves cardiac function. A first-in-man clinical (NCT01473433) trial showed that the AGTP is safe in patients.
Eligibility
Inclusion Criteria4
- > 18 years of age, capable of giving informed consent.
- Q wave in the ECG
- Myocardial infarct >=50% transmularity by NMR non revascularizable (for transmurality or bad vessel).
- Candidate to bypass for other myocardial areas
Exclusion Criteria8
- Severe non cardiac co-morbidity with a reduction of life expectancy of less than 1 year
- Severe valvular disease candidate for surgical restoration
- Candidate to ventricular remodeling
- Contraindication for NMR
- Severe renal or hepatic failure
- Abnoraml laboratory tests (no explanation at inclusion)
- Previous cardiac intervention
- Pregnant or breast feeding women
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Interventions
Patients with a myocardial necrosis candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be covered with the adipose graft and the revascularizable area will be treated with the normal procedure (by-pass).
Patients with a myocardial necrosis, candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be left untouched and the revascularizable area will be treated normally (by-pass).
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT02798276