Ventricular Tachycardia Mechanisms
Primary Purpose
Ventricular Tachycardia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Monophasic Action Potential (MAP) Catheter
Sponsored by
About this trial
This is an interventional basic science trial for Ventricular Tachycardia focused on measuring Ventricular tachycardia ablation
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
Sites / Locations
- Emory University Hospital MidtownRecruiting
- Emory ClinicRecruiting
- Emory University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Monophasic Action Potential (MAP) Catheter
Arm Description
Participants undergoing ventricular tachycardia ablation per standard of care will also have cellular action potential of the ventricular myocardium assessed with the MAP catheter.
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Identify mechanisms of slowed conduction at ILAM
The mechanisms responsible for slowed conduction at sites that are critical to ventricular tachycardia using monophasic action potential signals will be examined.
Identify surrogate markers
Surrogate markers for monophasic action potential tracings will be compared to conventional mapping catheters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05478213
Brief Title
Ventricular Tachycardia Mechanisms
Official Title
Ventricular Tachycardia Substrate Mechanisms Revealed by Local Repolarization and Conduction Parameters
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
Ventricular tachycardia ablation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Monophasic Action Potential (MAP) Catheter
Arm Type
Experimental
Arm Description
Participants undergoing ventricular tachycardia ablation per standard of care will also have cellular action potential of the ventricular myocardium assessed with the MAP catheter.
Intervention Type
Device
Intervention Name(s)
Monophasic Action Potential (MAP) Catheter
Other Intervention Name(s)
EasyMap catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Waveform Morphology
Description
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.
Time Frame
During ablation on Day 1
Title
Conduction Velocity
Description
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).
Time Frame
During ablation on Day 1
Secondary Outcome Measure Information:
Title
Identify mechanisms of slowed conduction at ILAM
Description
The mechanisms responsible for slowed conduction at sites that are critical to ventricular tachycardia using monophasic action potential signals will be examined.
Time Frame
During ablation on Day 1
Title
Identify surrogate markers
Description
Surrogate markers for monophasic action potential tracings will be compared to conventional mapping catheters.
Time Frame
During ablation on Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neal Bhatia, MD
Phone
404-686-7878
Email
neal.kumar.bhatia@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Bhatia, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Ventricular Tachycardia Mechanisms
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