NCT06575881 Defining the Risk of Ventricular Tachycardia in Genetic Cardiomyopathies
| NCT ID | NCT06575881 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-12-13 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-12-13 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to determine if electrophysiologic mapping and cardiac MRI can help identify patients that have genetic forms of cardiomyopathy that are at high risk for development of dangerous ventricular arrhythmias. The investigators aim to study: 1. the prevalence and mechanism of inducible ventricular tachycardia 2. pace-mapping to define the site of origin of ventricular arrhythmias 3. voltage mapping to define low voltage scar substrate in the basal LV to determine the risk of development of ventricular arrhythmias in patients with genetic forms of cardiomyopathy. Participants will undergo cardiac MRI before their scheduled procedure and voltage mapping during their scheduled procedure as part of data collection.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06575881 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06575881 currently recruiting?
Yes, NCT06575881 is actively recruiting participants. Contact the research team at dakota.grauherr@vumc.org for enrollment information.
Where is the NCT06575881 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT06575881 clinical trial?
NCT06575881 is sponsored by Vanderbilt University Medical Center. The trial plans to enroll 200 participants.
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