Status:
TERMINATED
Electrogram-Guided Myocardial Advanced Phenotyping
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Biosense Webster, Inc.
Conditions:
Non-ischemic Cardiomyopathy
Eligibility:
All Genders
Brief Summary
Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy.
Detailed Description
Non-Ischemic Cardiomyopathy (NICM) is a common cause of heart failure (HF) and death. NICM is a heterogeneous entity, and specific etiologies are infrequently identified. In part due to limited diseas...
Eligibility Criteria
Inclusion
- 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
- \-
Exclusion
- 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
- Primary hypertrophic cardiomyopathy
- Untreated thyroid disease
- Severe nutritional deficiency
- Severe uncontrolled hypertension
- Sepsis, active infection (excluding cystitis) or other comorbidity driving the HF decompensation
- History of cardiac transplantation
- Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, INR \> 1.5 in the absence of anticoagulation treatment
- Inability to comply with planned study procedures
- \-
Key Trial Info
Start Date :
November 30 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03293381
Start Date
November 30 2018
End Date
November 30 2024
Last Update
April 6 2025
Active Locations (2)
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1
Mayo clinic
Rochester, Minnesota, United States, 55905
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19054