NCT03293381

Electrogram-Guided Myocardial Advanced Phenotyping

Electrogram-Guided Myocardial Advanced Phenotyping (The eMAP Trial)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 disease characterization, specific treatments are lacking for most of the different underlying causes of NICM. Depending on the cohort, 30-70 percent of patients with new-onset NICM develop persistent systolic dysfunction despite guideline-directed medical therapy, and these patients have high rates of subsequent morbidity and resource utilization. Current guidelines support the use of endomyocardial biopsy (EMB) in patients with both new-onset and persistent cardiomyopathy. However, EMB is underutilized in these populations due to its low diagnostic yield. A combination of sampling error resulting from standard fluoroscopy-guided EMB in disease entities with patchy myocardial involvement and rudimentary tissue phenotyping of the specimens which are obtained contribute to this low diagnostic yield. In recent years, there has been increasing interest in the use of electro-anatomic mapping (EAM) to help identify areas of myocardium with discrete pathology based on abnormalities in intra-cardiac electrogram voltage and morphologies. Therefore, the primary objective of this protocol is to provide definitive evidence that EAM-guided biopsy leads to a superior diagnostic yield compared with conventional fluoroscopy-guided biopsy in patients with new-onset and persistent NICM.

Conditions

• Non-ischemic Cardiomyopathy

Interventions

Type	Name	Description
DEVICE	additional biopsies	additional biopsies

Timeline

• Start date: 2018-11-30
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2017-09-26
• Last updated: 2025-04-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study