Computational Cardiac Imaging Analysis to Guide Ventricular Tachycardia Ablation Procedures (AI-VT)

Not Applicable

• Conditions: Ventricular Tachycardia (VT); Premature Ventricular Contraction (PVC); Ventricular Fibrillation

• Registration Number: NCT06964152
• Lead Sponsor: University of California, San Diego

Brief Summary

The purpose of this study is to evaluate the clinical outcomes (clinical efficacy and safety) of using supplemental non-invasive computational ECG and cardiac imaging analysis tools to help guide ablation of ventricular tachycardia.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study First Posted: 2025-05-09
• Last Update Posted: 2025-05-09
• Primary Completion: 2029-12-31
• Study Completion: 2034-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Age between 21 and 100
2. Evidence of ventricular tachycardia on ECG, telemetry or by CIED interrogation.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Recurrent ventricular tachycardia	1 year	Ventricular tachycardia episodes defined as implantable cardioverter defibrillator (ICD) therapies (anti-tachycardia pacing and shocks)
All-cause death	1 year

Secondary Outcome Measures

Name	Time	Method
acute pericardial tamponade requiring intervention	24 hours post-op	new expanding hemorrhagic pericardial effusion causing tamponade requiring urgent pericardiocentesis
vascular complication requiring intervention	24 hours post-op	vascular access complication (bleeding or occlusion) requiring blood transfusion or vascular procedure (such as peripheral angioplasty)
Acute hemodynamic decompensation	24 hours post-op	acute development of hypotension, cardiogenic shock, escalation of inotropes/pressors, or need for unplanned percutaneous hemodynamic support
Unplanned prolonged ICU upgrade	48 hours	In outpatient elective cases, change in patient condiction neccessitating unplanned ICU upgrade lasting longer than 48 hours.
acute cerebrovascular accident (embolic)	24 hours post-op

Trial Locations

Locations (1)

UC San Diego Health; 🇺🇸 La Jolla, California, United States