Identifying risks of dangerous heart rhythms in genetic heart conditions
Defining the Risk of Ventricular Tachycardia in Genetic Forms of Early-onset Atrial Fibrillation
This study is trying to see if special heart tests can help find people with genetic heart conditions who are at risk for serious heart rhythm problems.
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 | NCT06575881 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine if electrophysiologic mapping and cardiac MRI can identify patients with genetic cardiomyopathies who are at high risk for developing dangerous ventricular arrhythmias. The study will assess the prevalence and mechanisms of inducible ventricular tachycardia, utilize pace-mapping to locate the origins of ventricular arrhythmias, and perform voltage mapping to identify low voltage scar substrates in the heart. Participants will undergo cardiac MRI and voltage mapping as part of the data collection process to enhance understanding of how genetic factors influence arrhythmia risk.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with atrial fibrillation, frequent premature ventricular contractions, or ventricular tachycardia before age 60, who are scheduled for catheter-based ablation procedures.
Not a fit: Patients with a prior diagnosis of a genetic cardiomyopathy or arrhythmia syndrome, or those with certain severe heart conditions, 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 genetic cardiomyopathies.
How similar studies have performed: Other studies have shown success in using genetic insights to inform clinical management of arrhythmias, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 and older * Diagnosed with AF, frequent PVCs, or VT before age 60 * Scheduled for catheter-based AF ablation (de-novo or repeat) OR catheter-based PVC ablation OR catheter-based VT ablation * Able to provide written, informed consent * P/LP variant in TTN or other CM gene (cases) or identified as a genotype-negative control. Exclusion Criteria: * Diagnosed with a genetic CM or arrhythmia syndrome prior to ablation procedure * VUS in 'possibly pathogenic' subgroup (control group only) * Previous PVC or VT ablation * LVEF \<20% * Prosthetic mitral or aortic valve * Contraindication to heparin * Prior myocardial infarction
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Dakota Graherr, RN
- Email: dakota.grauherr@vumc.org
- Phone: 615-936-6069
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.