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

RECRUITINGN/ASponsored by Antoni Bayés Genís
Actively Recruiting
PhaseN/A
SponsorAntoni Bayés Genís
Started2017-03-01
Est. completion2025-10
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT02798276

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Heart DiseaseMyocardial Infarction

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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