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Defining the Risk of Ventricular Tachycardia in Genetic Forms of Early-onset Atrial Fibrillation

Defining the Risk of Ventricular Tachycardia in Genetic Forms of Early-onset Atrial

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06647459
Enrollment
32
Registered
2024-10-17
Start date
2023-12-13
Completion date
2026-04-28
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Ventricular Tachycardia

Keywords

catheter ablation, genomics

Brief 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 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.

Interventions

DIAGNOSTIC_TESTEP Study

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.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Adults aged 18 and older 2. Diagnosed with AF before age 60 3. Scheduled for catheter-based AF ablation (de-novo or repeat) 4. Able to provide written, informed consent 5. P/LP variant in TTN or other CM gene (cases) or identified as a genotype-negative control.

Exclusion criteria

1. Diagnosed with a genetic CM or arrhythmia syndrome prior to AF 2. VUS in 'possibly pathogenic' subgroup (control group only) 3. Pacemaker or ICD 4. Previous PVC or VT ablation 5. LVEF \<20% 6. Prosthetic mitral or aortic valve 7. Contraindication to heparin 8. Prior myocardial infarction.

Design outcomes

Primary

MeasureTime frameDescription
VT InducibilityAt the time of procedureThe 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 siteAt the time of procedureThe 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 substrateAt the time of procedureThe primary endpoint is the presence of low voltage (yes/no) in the basal LV.

Secondary

MeasureTime frameDescription
Site of origin for ventricular arrhythmiasAt the time of procedureSecondary 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.
Evaluation of electrogram potentialsAt the time of procedureSecondary analyses will explore multicomponent electrograms and fractionated potentials that can be created by scar.
Presence of low voltageAt the time of procedureOther 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMoore B Shoemaker, MD

Vanderbilt University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026