NCT01473433

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

Randomized Trial to Evaluate the Safety and Efficacy of a New Surgical Approach to Cardiac Regeneration: Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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 myocardium.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	Pericardial adipose pedicle (adiFLAP) transposition.	Patients with a established transmural necrosis, candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be covered by the adiFLAP and the revascularizable area will be treated with the normal procedure. A non-revascularizable area will be considered whenever a transmural necrosis is detected by means of gadolinium contrast using MRI.
OTHER	Control	Patients with a established transmural 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).

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2011-11-17
• Last updated: 2015-07-24

Locations

1 site across 1 country: Spain