Ventricular Tachycardia Mechanisms

NCT05478213 | Recruiting FDA Device

• 2 other identifiers: STUDY000035712024P008207
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to understand why certain hearts have ventricular arrhythmias and help identify areas of the heart that cause arrhythmias. There is still a significant gap in understanding why ventricular arrhythmias occur. This study will examine the electrical properties of the heart tissue to understand how these arrhythmias occur, and hopefully identify areas that might lead to ventricular arrhythmias. The hope is that studying this might be able to improve outcomes during ventricular tachycardia (VT) ablations.

Conditions

Ventricular Tachycardia

Keywords

Ventricular tachycardia ablation

Outcome Measures

Primary Outcomes (2)

• Waveform Morphology

  Identification of sites that are critical to reentry of ventricular tachycardia from bystander sites will be performed by analyzing local ventricular activation. Local ventricular action is assessed with waveform morphology and is measured in voltage (mV). The normal range is \>3 mV bipolar and \>8.3 mV unipolar.

  During ablation on Day 1

• Conduction Velocity

  Identification of sites that are critical to reentry of ventricular tachycardia from bystander sites will be performed by analyzing electrophysiological properties. Electrophysiological properties are assessed with conduction velocity, measured in meters per second (m/s).

  During ablation on Day 1

Secondary Outcomes (2)

• Identify mechanisms of slowed conduction at ILAM

  During ablation on Day 1

• Identify surrogate markers

  During ablation on Day 1

Study Arms (1)

Monophasic Action Potential (MAP) Catheter

EXPERIMENTAL

Participants undergoing ventricular tachycardia ablation per standard of care will also have cellular action potential of the ventricular myocardium assessed with the MAP catheter.

Device: Monophasic Action Potential (MAP) Catheter

Interventions

Monophasic Action Potential (MAP) Catheter DEVICE

The EasyMap catheter is a temporary quadripolar catheter for recording monophasic action potentials and for intracardiac pacing. During a standard of care VT ablation, the MAP catheter will be used to study cellular action potential of the ventricular myocardium, which cannot be done on traditional catheters. The catheter is placed on the myocardium (similar to other traditional catheters) and a recording signal is transmitted to the workstation. Using the MAP catheter the will not interrupt or distort any of the standard treatment procedures.

Also known as: EasyMap catheter

Monophasic Action Potential (MAP) Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ischemic cardiomyopathy
• Single or dual chamber implantable cardioverter-defibrillator (ICD)

You may not qualify if:

• Non-Ischemic cardiomyopathy
• Contraindication to catheter ablation
• Severe peripheral arterial disease or medical condition that prohibit arterial access
• Ventricular tachycardia (VT) or sudden cardiac arrest (SCA) within 30 days of acute coronary syndrome or within 90 days of coronary revascularization

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory Clinic

Atlanta, Georgia, 30322, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Catheters

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Neal Bhatia, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neal Bhatia, MD

CONTACT

404-686-7878; neal.kumar.bhatia@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 28, 2022
• Study Start: October 25, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)