Electrogram-Guided Myocardial Advanced Phenotyping

NCT03293381 | Terminated DMC FDA Device

• 1 other identifier: 826102
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Non-ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

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

  Additional biopsies

  November 2018

Interventions

additional biopsies DEVICE

additional biopsies

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Biosense Webster, Inc.: collaborator

Study Sites (2)

Mayo clinic

Rochester, Minnesota, 55905, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19054, United States

Location

Study Officials

• Francis Marchlinski, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 26, 2017
• Study Start: November 30, 2018
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

US (2)