Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)

Germans Trias i Pujol Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Myocardial Infarction

Treatments: Procedure: Pericardial adipose pedicle (adiFLAP) transposition.; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01473433

ICREC-2011-02

Details and patient eligibility

About

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 infarct. Preclinical studies in the porcine model of myocardial infarction have shown that AdiFLAP reduces infarct area.

Full 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 myocardium.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Control

Other group

Description:

Patients in which the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.

Treatment:

Other: Control

adiFLAP

Experimental group

Description:

Patients in which the non-revascularizable area will be covered by the adiFLAP and the revascularizable area will be treated with the normal procedure.

Treatment:

Procedure: Pericardial adipose pedicle (adiFLAP) transposition.