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Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial

Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar: The AGTP II Trial

Recruiting
18 years and older
All
Phase N/A

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Overview

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 Criteria:

  • > 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 Criteria:

  • 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

Study details
    Myocardial Infarction

NCT02798276

Antoni Bayés Genís

8 March 2024

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