Recruiting

Observational Study

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06575881

Conditions

Atrial Fibrillation

Ventricular Tachycardia

Premature Ventricular Contraction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Atrial Fibrillation

Ventricular Tachycardia

Premature Ventricular Contraction

Study ID

NCT06575881

Start date

Dec 13, 2023

Status verified date

Apr, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

TTN-positive

Patients with a pathogenic or likely pathogenic variant in TTN on clinical genetic testing.

Gene-positive

Patients with a pathogenic or likely pathogenic variant in a gene other than TTN on clinical genetic testing.

Gene-negative

Patients without a pathogenic or likely pathogenic variant in a cardiomyopathy or arrhythmia gene on clinical genetic testing.

Primary outcome measure

  • Ventricular Tachycardia Inducibility [ Time Frame: During procedure ]

Central Contacts and Locations

Central contacts

Dakota Graherr, RN

615-936-6069dakota.grauherr@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

May 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-05-06.