VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Apr 22, 2025

Keywords

ClinConnect Summary

The VINTAGE clinical trial is studying a new approach to treat ventricular arrhythmias, which are irregular heartbeats that can cause serious heart problems or even death. This trial focuses on patients who have already tried other treatments without success. The VINTAGE method uses special catheters that can navigate inside the heart’s walls to target and treat difficult areas causing these arrhythmias. Early results show that this method can effectively reduce or eliminate abnormal heart rhythms in patients who haven't responded well to previous treatments.

To be eligible for this trial, participants must be at least 21 years old and have had at least one unsuccessful catheter ablation procedure for their ventricular arrhythmias. They should also be experiencing symptoms like uncomfortable heartbeats, fainting, or heart failure. Participants will need to commit to follow-up visits to monitor their progress. This trial is currently not recruiting patients, but it aims to provide valuable information on how to better treat this challenging condition.

Gender

ALL

Eligibility criteria

• * 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