Defining the Risk of Ventricular Tachycardia in Genetic Cardiomyopathies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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%
Trial population
Young patients with atrial fibrillation, frequent PVCs, or VT that are scheduled to undergo procedural management of their arrhythmia.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 3 trial groupsGroup A: TTN-positive
Group B: Gene-positive
Group C: Gene-negative
Trial outcomes
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.
Time frame
During procedureSecondary outcomes
1
Site and Substrate of Ventricular Ectopy
Localization of ventricular ectopy or arrhythmia will be evaluated during the procedure by electoanatomic mapping, and the assessment of scar burden in this area (by voltage mapping) will be secondary outcomes for Aims 1B and 1C.
Time frame
During procedureSponsors and contacts
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Source ClinicalTrials.gov