Status:
NOT_YET_RECRUITING
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Ventricular Arrhythmia
Eligibility:
All Genders
21-100 years
Phase:
NA
Brief Summary
Background: Ventricular arrhythmia is an abnormal pulse rhythm that starts in the lower part of the heart (ventricles). Treatment includes ablation; ablation uses heat to destroy small portions of th...
Detailed Description
Ventricular arrhythmias cause heart damage or death. Ventricular arrhythmias usually arise from small zones of the heart that contribute a short circuit or errant stimulus. Ventricular arrhythmias may...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Candidates must meet all of the following criteria:
- Age \>= 21 years
- Undergoing planned repeat radiofrequency catheter ablation for ventricular arrhythmias (Having failed a previous attempt at catheter ablation and at least one antiarrhythmic drug for ventricular arrhythmias)
- Ventricular arrhythmia COHORT 1:
- Monomorphic ventricular tachycardia
- Has an implanted cardioverter defibrillator (ICD)
- Hospital admission for ventricular tachycardia since most recent ablation attempt
- Ventricular arrhythmia COHORT 2:
- -Monomorphic (unifocal), frequent, premature ventricular contraction, \>=15% burden
- Naive pericardium (no prior cardiac surgery)
- Either of
- Symptomatic (intolerable palpitation, syncope, fatigue, dyspnea, heart failure, hospital admission for ventricular arrhythmia, appropriate ICD discharge, appropriate antitachycardia pacing), OR
- Left ventricular ejection fraction \< 0.50
- Willing to return for all scheduled follow-up activities, and eligible or able to undergo required protocol and testing
- EXCLUSION CRITERIA:
- Does not consent to participate, or unable to consent to participate
- Left ventricular ejection fraction \< 0.20
- Hemodynamic instability or emergency procedure
- Requires planned temporary mechanical circulatory device (such as percutaneous left ventricular assist device or intraaortic balloon counterpulsation pump)
- Pregnant
- eGFR \< 30 mL/min/1.73m\^2 or end-stage renal failure requiring renal replacement therapy
- Survival despite successful procedure expected \< 6 mo
Exclusion
Key Trial Info
Start Date :
January 14 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06940752
Start Date
January 14 2026
End Date
July 1 2027
Last Update
January 9 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Emory University
Atlanta, Georgia, United States, 30322-1102