Non-ischemic CardiomyopathyeMAPNCT03293381
Electrogram-Guided Myocardial Advanced Phenotyping
An observational study of Non-ischemic Cardiomyopathy, run by University of Pennsylvania at 2 sites in United States.
Trial summary
Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-ischemic Cardiomyopathy
- What is being tested?
- additional biopsies
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2018to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with New onset NICM that are scheduled for a biopsy as part of their clinical care
Who may be able to join
- 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
- -
Who cannot join
- 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
Show all 17Show fewer
- 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
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19054
Mayo clinic
Rochester, Minnesota, 55905
About this study
Official title: Electrogram-Guided Myocardial Advanced Phenotyping (The eMAP Trial)
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.
- Conditions
- Non-ischemic Cardiomyopathy
- Being tested
- additional biopsies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional biopsiesDevice
additional biopsies
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy.
Additional biopsies
Measured: November 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start30 Nov 2018
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Why it stopped: As per the investigators decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
- Investigators
- Francis Marchlinski, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293381
- Sponsor's protocol ID
- 826102
- Acronym
- eMAP
- Status last verified
- Apr 2025
- First submitted
- 21 Sep 2017
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrogram-Guided Myocardial Advanced Phenotyping (The eMAP Trial)
- ClinicalTrials.gov ID
- NCT03293381
- Acronym / sponsor ID
- eMAP / 826102
- Conditions
- Non-ischemic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: As per the investigators decision
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with New onset NICM that are scheduled for a biopsy as part of their clinical care
Key inclusion criteria (5 listed)
- 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
- -
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| additional biopsiesadditional biopsies | Device | – |
Primary outcome
Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy.
Time frame: November 2018
Additional biopsies
Results and safety
The study was stopped early (reason given: As per the investigators decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Marchlinski, MD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-ischemic Cardiomyopathy, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: As per the investigators decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy. (time frame: November 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.