Ventricular TachycardiaNCT06647459
Defining the Risk of Ventricular Tachycardia in Genetic Forms of Early-onset Atrial Fibrillation
An observational study of Ventricular Tachycardia and Atrial Fibrillation, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
To use programmed ventricular stimulation at the time of AF ablation to define the prevalence and mechanism of inducible ventricular tachycardia (VT); pace-mapping to define the site of origin of ventricular arrhythmias; and voltage mapping to define low voltage scar substrate in the basal LV in patients with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventricular Tachycardia, Atrial Fibrillation
- What is being tested?
- EP Study
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2023to 28 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with early-onset AF are referred to our Vanderbilt AF Precision Medicine Clinic and undergo clinical genetic testing with a CM/arrhythmia panel and a comprehensive clinical evaluation including a cardiac MRI. 50% of patients are referred to undergo AF ablation to treat symptomatic AF. For all eligible patients, the study will be described either in person, or be contacted via phone with an approved phone script. If interested, participants sign the written informed consent (paper option or e-consent option).
Who may be able to join
- Adults aged 18 and older
- Diagnosed with AF before age 60
- Scheduled for catheter-based AF ablation (de-novo or repeat)
- Able to provide written, informed consent
- P/LP variant in TTN or other CM gene (cases) or identified as a genotype-negative control.
Who cannot join
- Diagnosed with a genetic CM or arrhythmia syndrome prior to AF
- VUS in 'possibly pathogenic' subgroup (control group only)
- Pacemaker or ICD
- Previous PVC or VT ablation
- LVEF <20%
- Prosthetic mitral or aortic valve
- Contraindication to heparin
- Prior myocardial infarction.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Defining the Risk of Ventricular Tachycardia in Genetic Forms of Early-onset Atrial
To use programmed ventricular stimulation at the time of AF ablation to define the prevalence and mechanism of inducible ventricular tachycardia (VT); pace-mapping to define the site of origin of ventricular arrhythmias; and voltage mapping to define low voltage scar substrate in the basal LV in patients with pathogenic TTN variants compared to genotype-negative controls.
Read the detailed description
Participants will undergo AF ablation according to standard, contemporary techniques. The procedure will be performed under general anesthesia. As part of routine standard of care in patients with early-onset AF or patients who have PVCs, we will also test for inducibility of VT using a standardized pacing protocol. The research protocol will include LV mapping and identification of low voltage substrate using electroanatomical mapping as described below.
- Conditions
- Ventricular Tachycardia, Atrial Fibrillation
- Being tested
- EP Study
- Keywords
- catheter ablation, genomics
- Medical subject headings
- Tachycardia, Ventricular, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP StudyDiagnostic test
Also called Mapping
To use programmed ventricular stimulation at the time of AF ablation to define the prevalence and mechanism of inducible ventricular tachycardia (VT); pace-mapping to define the site of origin of ventricular arrhythmias; and voltage mapping to define low voltage scar substrate in the basal LV in patients with pathogenic TTN variants compared to genotype-negative controls.
| Study group | Role | What they receive |
|---|---|---|
| Pathogenic variant in TTN | 50 patients with a pathogenic variant in TTN Receives: Diagnostic Test: EP Study | |
| Pathogenic variant in other cardiomyopathy genes | 50 patients with a pathogenic variant in other cardiomyopathy genes Receives: Diagnostic Test: EP Study | |
| Genotype-negative controls | 100 genotype-negative controls Receives: Diagnostic Test: EP Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
VT Inducibility
The primary endpoint is induction of sustained VT that is determined to be reentrant or likely-reentrant. Sustained VT will be defined as VT lasting 30 seconds or requiring termination with burst pacing or cardioversion due to hemodynamic instability.
Measured: At the time of procedure
Presence of ventricular arrhythmias per specific site
The primary endpoint is the occurrence (yes/no) of ventricular arrhythmias (PVCs, NSVT, sustained VT) that are mapped to the basal LV as defined above.
Measured: At the time of procedure
Low voltage substrate
The primary endpoint is the presence of low voltage (yes/no) in the basal LV.
Measured: At the time of procedure
Secondary outcomes (3)
Site of origin for ventricular arrhythmias
Secondary analyses will explore the rate of ventricular arrhythmias in other segments of the LV and RV and will compare the site of origin for ventricular arrhythmias in the group of participants with pathogenic variants in other CM genes.
Measured: At the time of procedure
Evaluation of electrogram potentials
Secondary analyses will explore multicomponent electrograms and fractionated potentials that can be created by scar.
Measured: At the time of procedure
Presence of low voltage
Other secondary analyses will compare the presence of low voltage and the other secondary endpoints in the group of participants with pathogenic variants in other CM genes.
Measured: At the time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start13 Dec 2023
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
Why it stopped: Grant proposal was sent to NIH 3 times but did not score well enough to receive funding
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 Vanderbilt University Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Benjamin Shoemaker, Vanderbilt University Medical Center
- Investigators
- Moore B Shoemaker, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647459
- Sponsor's protocol ID
- 231260
- Status last verified
- Apr 2026
- First submitted
- 15 Oct 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Risk of Ventricular Tachycardia in Genetic Forms of Early-onset Atrial
- ClinicalTrials.gov ID
- NCT06647459
- Acronym / sponsor ID
- 231260
- Conditions
- Ventricular Tachycardia, Atrial Fibrillation
- Keywords
- catheter ablation, genomics
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Grant proposal was sent to NIH 3 times but did not score well enough to receive funding
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 17 Oct 2024 (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.
To use programmed ventricular stimulation at the time of AF ablation to define the prevalence and mechanism of inducible ventricular tachycardia (VT); pace-mapping to define the site of origin of ventricular arrhythmias; and voltage mapping to define low voltage scar substrate in the basal LV in patients with pathogenic TTN variants compared to genotype-negative controls.
Detailed description
Participants will undergo AF ablation according to standard, contemporary techniques. The procedure will be performed under general anesthesia. As part of routine standard of care in patients with early-onset AF or patients who have PVCs, we will also test for inducibility of VT using a standardized pacing protocol. The research protocol will include LV mapping and identification of low voltage substrate using electroanatomical mapping as described below.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pathogenic variant in TTN | – | Diagnostic Test: EP Study50 patients with a pathogenic variant in TTN |
| Pathogenic variant in other cardiomyopathy genes | – | Diagnostic Test: EP Study50 patients with a pathogenic variant in other cardiomyopathy genes |
| Genotype-negative controls | – | Diagnostic Test: EP Study100 genotype-negative controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with early-onset AF are referred to our Vanderbilt AF Precision Medicine Clinic and undergo clinical genetic testing with a CM/arrhythmia panel and a comprehensive clinical evaluation including a cardiac MRI. 50% of patients are referred to undergo AF ablation to treat symptomatic AF. For all eligible patients, the study will be described either in person, or be contacted via phone with an approved phone script. If interested, participants sign the written informed consent (paper option or e-consent option).
Key inclusion criteria (5 listed)
- Adults aged 18 and older
- Diagnosed with AF before age 60
- Scheduled for catheter-based AF ablation (de-novo or repeat)
- Able to provide written, informed consent
- P/LP variant in TTN or other CM gene (cases) or identified as a genotype-negative control.
Key exclusion criteria (8 listed)
- Diagnosed with a genetic CM or arrhythmia syndrome prior to AF
- VUS in 'possibly pathogenic' subgroup (control group only)
- Pacemaker or ICD
- Previous PVC or VT ablation
- LVEF <20%
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 |
|---|---|---|
| EP StudyAlso: MappingTo use programmed ventricular stimulation at the time of AF ablation to define the prevalence and mechanism of inducible ventricular tachycardia (VT); pace-mapping to define the site of origin of ventricular arrhythmias; and voltage mapping to define low voltage scar substrate in the basal LV in patients with pathogenic TTN variants compared to genotype-negative controls. | Diagnostic test | Genotype-negative controls, Pathogenic variant in TTN, Pathogenic variant in other cardiomyopathy genes |
Primary outcome
VT Inducibility
Time frame: At the time of procedure
The primary endpoint is induction of sustained VT that is determined to be reentrant or likely-reentrant. Sustained VT will be defined as VT lasting 30 seconds or requiring termination with burst pacing or cardioversion due to hemodynamic instability.
Presence of ventricular arrhythmias per specific site
Time frame: At the time of procedure
The primary endpoint is the occurrence (yes/no) of ventricular arrhythmias (PVCs, NSVT, sustained VT) that are mapped to the basal LV as defined above.
Low voltage substrate
Time frame: At the time of procedure
The primary endpoint is the presence of low voltage (yes/no) in the basal LV.
3 secondary outcomes
Site of origin for ventricular arrhythmias
Time frame: At the time of procedure
Evaluation of electrogram potentials
Time frame: At the time of procedure
Presence of low voltage
Time frame: At the time of procedure
Results and safety
The study was stopped early (reason given: Grant proposal was sent to NIH 3 times but did not score well enough to receive funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Moore B Shoemaker, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and Atrial Fibrillation, run by Vanderbilt University Medical Center at 1 site 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Grant proposal was sent to NIH 3 times but did not score well enough to receive funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VT Inducibility (time frame: At the time of procedure). The study lists 3 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 6 May 2026.