Defining the Risk of Ventricular Tachycardia in Genetic Cardiomyopathies

NCT06575881 | Recruiting DMC

• 1 other identifier: IRB231260
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.the prevalence and mechanism of inducible ventricular tachycardia
2. 2.pace-mapping to define the site of origin of ventricular arrhythmias
3. 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.

Conditions

Atrial Fibrillation; Ventricular Tachycardia; Premature Ventricular Contraction

Outcome Measures

Primary Outcomes (1)

• Ventricular Tachycardia Inducibility

  Patients will undergo an electrophysiology study (EP study) as part of the research or clinical protocol for the procedure. Inducible VT (yes/no) with the EP study will be the primary outcome measure.

  During procedure

Secondary Outcomes (1)

• Site and Substrate of Ventricular Ectopy

  During procedure

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Young patients with atrial fibrillation, frequent PVCs, or VT that are scheduled to undergo procedural management of their arrhythmia.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia, Ventricular; Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease; Cardiac Complexes, Premature

Central Study Contacts

Dakota Graherr, RN

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: December 13, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (1)