Functional Substrate-Only Guided VT Ablation

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jun 14, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach to treat a serious heart condition called ventricular tachycardia (VT), which can lead to sudden cardiac death, especially among veterans. In current treatments, doctors usually destroy the problematic heart tissue causing VT. However, this study aims to see if focusing only on areas of the heart where electrical signals are slow (without trying to provoke VT) can make the procedure safer and more effective. By the end of the trial, researchers hope to find out if this method improves the success of treating dangerous heart rhythms.

To participate in this trial, individuals must be at least 18 years old and have specific types of VT related to existing heart problems, which are confirmed through various medical tests. Patients who have structural heart disease are eligible, but those without it, pregnant women, and individuals with certain health issues will not be included in the main study. Participants can expect to undergo a procedure that targets slow-conducting areas in the heart, with the goal of improving their heart health. This study is not yet recruiting participants, so there will be more information available when it officially starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women \>18 years of age referred for clinically indicated VT ablation and experience monomorphic or polymorphic scar-based VT documented by telemetry, ICD interrogation, ECG or event monitoring.
• • Scar-based VT is defined as VT in patients with structural heart disease (assessed with either abnormal nuclear perfusion imaging (\>5% defect), late gadolinium uptake on cardiac MRI, wall thinning \<10mm or calcified myocardium on cardiac CT, akinesis or hypokinesis on echocardiogram, presence of Q waves on ECG, history of myocardial infarct).
• • Patients undergoing epicardial VT ablation and who undergo prophylactic percutaneous hemodynamic support devices will also be included.
• Exclusion Criteria:
• • Patients without structural heart disease will be excluded from the pri-mary analysis, but enrolled in a prospective registry
• • Patients who are pregnant
• • Presence of intracardiac thrombus
• • active acute coronary ischemia with unrevascularized coronary artery disease (CAD \>70% stenosis)
• • Active bacteremia
• • Inaccessible ventricles due to dual mechanical valves
• • Inability to tolerate and inability to tolerate anticoagulation during ablation and for at least 1 month after ablation