A Phase 1/2 interventional study of Pericardial adipose pedicle (adiFLAP) transposition. and Control in Myocardial Infarction, sponsored by Germans Trias i Pujol Hospital. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-24.
Sponsored by Germans Trias i Pujol Hospital · Phase 1/2, Interventional, and Treatment
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.
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.
2,779 studies on the registry are indexed under Myocardial Infarction; 417 are open to participants now.
This study's enrollment of 10 is below the median of 148 across 1,613 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Germans Trias i Pujol Hospital is the lead sponsor of 88 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Patients in which the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.
Other: Control
Patients in which the non-revascularizable area will be covered by the adiFLAP and the revascularizable area will be treated with the normal procedure.
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.
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).
Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up).
Time frame: 12 months
Improvement of cardiac function as changes in clinical variables, cardiac magnetic resonance imaging and echocardiography, and biochemical variables (NTproBNP and high sensitivity troponin T).
Time frame: 12 months
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Germans Trias i Pujol Hospital