Electrogram-Guided Myocardial Advanced Phenotyping (eMAP)

Electrogram-Guided Myocardial Advanced Phenotyping (The eMAP Trial)

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Non-ischemic Cardiomyopathy
• Intervention / Treatment: Device: additional biopsies

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19054
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects with New onset NICM that are scheduled for a biopsy as part of their clinical care

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. 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.
3. 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.

4. Willingness to provide informed consent

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Exclusion Criteria:

1. Prior diagnosis of HF or documented LVEF < 45% more than 6 months prior to enrollment.
2. 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.
3. Ongoing hemodynamically significant arrhythmias deemed to be an independent cause of HF decompensation
4. Constrictive pericarditis or tamponade
5. Complex congenital heart disease
6. History of malignancy with treatment by anthracyclines or other known cardiotoxic chemotherapeutic agents
7. More than mild aortic or mitral stenosis
8. Intrinsic (prolapse, rheumatic) valve disease with severe mitral, aortic or tricuspid regurgitation
9. Primary hypertrophic cardiomyopathy
10. Untreated thyroid disease
11. Severe nutritional deficiency
12. Severe uncontrolled hypertension
13. Sepsis, active infection (excluding cystitis) or other comorbidity driving the HF decompensation
14. History of cardiac transplantation
15. 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

16. Inability to comply with planned study procedures

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy.	Additional biopsies	November 2018

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Biosense Webster, Inc.
• Investigators: Principal Investigator: Francis Marchlinski, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: 826102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No