TerminatedNot Applicable

Electrogram-Guided Myocardial Advanced Phenotyping

Stopped: As per the investigators decision

United States35 participantsStarted 2018-11-30

Plain-language summary

Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy.

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 years
✓. New onset NICM as defined by the presence of left ventricular dysfunction (LVEF \< 45% by echocardiography and/or MRI), with symptoms or signs of HF (dyspnea, orthopnea, edema, ascites, rales or pulmonary vascular congestion on chest radiography) of less than 3 months in duration.
✓. Persistent recent onset NICM as defined by the LVEF and signs/symptoms in #2 above with persistence of the LVEF \< 45% despite evidence-based treatment for HF with reduced LVEF for 2 to 6 months.
✓. Willingness to provide informed consent

✕. Prior diagnosis of HF or documented LVEF \< 45% more than 6 months prior to enrollment.
✕. Coronary artery disease, either by history or as determined by coronary angiography demonstrating hemodynamically significant lesions deemed sufficient to potentially contribute to left ventricular dysfunction.
✕. Ongoing hemodynamically significant arrhythmias deemed to be an independent cause of HF decompensation
✕. Constrictive pericarditis or tamponade
✕. Complex congenital heart disease
✕. History of malignancy with treatment by anthracyclines or other known cardiotoxic chemotherapeutic agents
✕. More than mild aortic or mitral stenosis
✕. Intrinsic (prolapse, rheumatic) valve disease with severe mitral, aortic or tricuspid regurgitation

Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy.

Timeframe: November 2018

NCT IDNCT03293381

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-11-30

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 years
✓. New onset NICM as defined by the presence of left ventricular dysfunction (LVEF \< 45% by echocardiography and/or MRI), with symptoms or signs of HF (dyspnea, orthopnea, edema, ascites, rales or pulmonary vascular congestion on chest radiography) of less than 3 months in duration.
✓. Persistent recent onset NICM as defined by the LVEF and signs/symptoms in #2 above with persistence of the LVEF \< 45% despite evidence-based treatment for HF with reduced LVEF for 2 to 6 months.
✓. Willingness to provide informed consent

✕. Prior diagnosis of HF or documented LVEF \< 45% more than 6 months prior to enrollment.
✕. Coronary artery disease, either by history or as determined by coronary angiography demonstrating hemodynamically significant lesions deemed sufficient to potentially contribute to left ventricular dysfunction.
✕. Ongoing hemodynamically significant arrhythmias deemed to be an independent cause of HF decompensation
✕. Constrictive pericarditis or tamponade
✕. Complex congenital heart disease
✕. History of malignancy with treatment by anthracyclines or other known cardiotoxic chemotherapeutic agents
✕. More than mild aortic or mitral stenosis
✕. Intrinsic (prolapse, rheumatic) valve disease with severe mitral, aortic or tricuspid regurgitation