Ventricular Tachycardia Mechanisms

NCT ID: NCT05478213

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-25
• Study Completion Date: 2025-12-31

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.

Detailed Description

Ventricular tachycardia (VT) ablation remains the cornerstone treatment for drug refractory VT. Previous studies have reported success rate of VT ablation ranging from 23 to 49%. Despite improvements in mapping and catheter technology, there is a high recurrence rate and numerous patients who fail VT ablation.

Reasons for failure in VT ablation include the inability to identify critical areas of myocardium responsible for VT and hemodynamic instability of VT during mapping. Several studies have attempted to study electrical properties of cardiac tissues to identify potential circuits in sinus rhythm avoid mapping during unstable VT. This includes mapping fractionated electrical potentials, isochronal late activation mapping (ILAM), and ablation of low voltage regions. However, these techniques have yielded modest improvement in success rates with poor specificity of identifying important regions.

Monophasic action potentials (MAP) demonstrate cellular action potential of the myocardium. Recent evidence suggests that changes in MAP morphology can predict sudden cardiac death by ventricular arrhythmias. However, cellular activation has not been studied in VT. The researchers of this study propose that MAP signals can better elucidate electrophysiological characteristics of the myocardium, and thus identify sites critical to VT.

During a standard of care VT ablation, the researchers will use the MAP catheter to study cellular action potential of the ventricular myocardium, which cannot be done on traditional catheters. The design of this catheter is similar to other diagnostic catheters that are currently used for VT ablation. The MAP catheter is a bipolar catheter, two with electrical poles at the distal tip. 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.

Conditions

Ventricular Tachycardia

Keywords

Ventricular tachycardia ablation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Monophasic Action Potential (MAP) Catheter

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

Group Type: EXPERIMENTAL

Monophasic Action Potential (MAP) Catheter

Intervention Type: 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.

Interventions

Monophasic Action Potential (MAP) Catheter

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.

Intervention Type: DEVICE

Other Intervention Names

EasyMap catheter

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Neal Bhatia

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neal Bhatia, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory Clinic

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Neal Bhatia, MD

Role: CONTACT

Phone: 404-686-7878

Email: neal.kumar.bhatia@emory.edu

Other Identifiers

2024P008207

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00003571

Identifier Type: -

Identifier Source: org_study_id