Assessing the risk of ventricular tachycardia in patients with early-onset atrial fibrillation
Defining the Risk of Ventricular Tachycardia in Genetic Forms of Early-onset Atrial
This study is testing if people with early-onset atrial fibrillation and certain genetic changes are more likely to have a fast heart rhythm called ventricular tachycardia during a heart procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06647459 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prevalence and mechanisms of inducible ventricular tachycardia (VT) in patients with early-onset atrial fibrillation (AF) and pathogenic TTN variants. Participants will undergo catheter-based AF ablation, during which programmed ventricular stimulation will be used to test for VT inducibility. Additionally, electroanatomical mapping will identify low voltage scar substrates in the left ventricle. The study compares these findings with genotype-negative controls to better understand the relationship between genetic factors and arrhythmias.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with atrial fibrillation before age 60 who are scheduled for catheter-based AF ablation.
Not a fit: Patients with a prior diagnosis of a genetic cardiomyopathy or arrhythmia syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management strategies for patients with early-onset atrial fibrillation.
How similar studies have performed: Other studies have explored the relationship between genetic factors and arrhythmias, but this specific approach to assessing VT in early-onset AF is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Moore B Shoemaker, MD — Vanderbilt University Medical Center
- Study coordinator: Dakota D Grauherr, RN
- Email: dakota.grauherr@vumc.org
- Phone: 615-714-8674
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.