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TerminatedNCT03293381eMAPUpdated Apr 6, 2025

Electrogram-Guided Myocardial Advanced Phenotyping

An observational study in Non-ischemic Cardiomyopathy, sponsored by University of Pennsylvania. Terminated at 2 sites in United States. Per ClinicalTrials.gov, last updated 2025-04-06.

Sponsored by University of Pennsylvania · Observational

Why this study was terminated
As per the investigators decision
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Non-ischemic Cardiomyopathy

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

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

Exclusion criteria

-

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

    -

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (actual)
Patient registry
No

Interventions

  • Deviceadditional biopsies

    additional biopsies

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What researchers measure

Primary outcomes

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

    Additional biopsies

    Time frame: November 2018

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Study locations

2 sites
  • Mayo clinic
    Rochester, Minnesota 55905, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19054, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03293381
Lead sponsor
University of Pennsylvania
Collaborators
Biosense Webster, Inc.
Responsible party
Sponsor
First posted
Sep 26, 2017
Start date
Nov 30, 2018
Primary completion
Nov 30, 2024
Completion
Nov 30, 2024
Last update
Apr 6, 2025

Study contacts

Francis Marchlinski, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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