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

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Atrial Fibrillation; Ventricular Tachycardia

Treatments: Diagnostic Test: EP Study

Study type: Observational

Funder types: Other

Identifiers

NCT06647459

231260

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

200 participants in 3 patient groups

Pathogenic variant in TTN

Description:

50 patients with a pathogenic variant in TTN

Treatment:

Diagnostic Test: EP Study

Pathogenic variant in other cardiomyopathy genes

Description:

50 patients with a pathogenic variant in other cardiomyopathy genes

Treatment:

Diagnostic Test: EP Study

Genotype-negative controls

Description:

100 genotype-negative controls

Treatment:

Diagnostic Test: EP Study