Ventricular TachycardiaNCT05478213
Ventricular Tachycardia Mechanisms
A study testing Monophasic Action Potential (MAP) Catheter in people with Ventricular Tachycardia, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Monophasic Action Potential (MAP) Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Oct 2022to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ischemic cardiomyopathy
- Single or dual chamber implantable cardioverter-defibrillator (ICD)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
- Recruiting
Emory Clinic
Atlanta, Georgia, 30322
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: Ventricular Tachycardia Substrate Mechanisms Revealed by Local Repolarization and Conduction Parameters
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.
Read the 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
- Being tested
- Monophasic Action Potential (MAP) Catheter
- Keywords
- Ventricular tachycardia ablation
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monophasic Action Potential (MAP) CatheterDevice
Also called EasyMap 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Monophasic Action Potential (MAP) Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: During ablation on Day 1
Secondary outcomes (2)
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.
Measured: During ablation on Day 1
Identify surrogate markers
Surrogate markers for monophasic action potential tracings will be compared to conventional mapping catheters.
Measured: During ablation on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start25 Oct 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neal Bhatia, Emory University
- Investigators
- Neal Bhatia, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478213
- Sponsor's protocol ID
- STUDY00003571
- Other IDs
- 2024P008207
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2022
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventricular Tachycardia Substrate Mechanisms Revealed by Local Repolarization and Conduction Parameters
- ClinicalTrials.gov ID
- NCT05478213
- Acronym / sponsor ID
- STUDY00003571
- Conditions
- Ventricular Tachycardia
- Keywords
- Ventricular tachycardia ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Jul 2022 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monophasic Action Potential (MAP) Catheter | Experimental | Device: Monophasic Action Potential (MAP) CatheterParticipants undergoing ventricular tachycardia ablation per standard of care will also have cellular action potential of the ventricular myocardium assessed with the MAP catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of ischemic cardiomyopathy
- Single or dual chamber implantable cardioverter-defibrillator (ICD)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Monophasic Action Potential (MAP) CatheterAlso: EasyMap catheterThe 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. | Device | Monophasic Action Potential (MAP) Catheter |
Primary outcome
Waveform Morphology
Time frame: During ablation on Day 1
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
Time frame: During ablation on Day 1
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).
2 secondary outcomes
Identify mechanisms of slowed conduction at ILAM
Time frame: During ablation on Day 1
Identify surrogate markers
Time frame: During ablation on Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
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.
Neal Bhatia, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monophasic Action Potential (MAP) Catheter in people with Ventricular Tachycardia, run by Emory University at 3 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neal Bhatia, MD (404-686-7878, neal.kumar.bhatia@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waveform Morphology (time frame: During ablation on Day 1). The study lists 2 primary outcomes in all. 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 30 Jun 2026.