NCT06940752

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · NIH
• Sex: All
• Age: 21 Years – 100 Years
• Healthy volunteers: Not accepted

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 the heart that are causing short circuits in the normal heartbeats. But ablation does not always work well because some parts of the heart are hard to reach with current tools. Researchers want to try a new method called VINTAGE (ventricular intramyocardial navigation for tachycardia ablation guided by electrograms). VINTAGE may be better able to treat portions of the heart that are harder to reach with standard techniques. Objective: To test VINTAGE in people with ventricular arrhythmia. Eligibility: People aged 21 years and older with ventricular arrhythmia that did not respond to standard treatment. Design: Participants will have baseline tests. They will have blood tests and tests of their heart function. They will have imaging scans. They will complete a health questionnaire. Participants will undergo the VINTAGE procedure. They will be either completely or partially asleep. Doctors will insert tubes through large blood vessels in the groin. Tubes may also be inserted through the chest and wrist. They will use x-rays and ultrasound to guide tubes and guidewires directly into the heart muscle to do the ablation. Participants will stay in the hospital 1 or more nights after the procedure. Participants will have 3 follow-up visits over 6 months. These visits are for standard care after heart ablation. They will include blood tests, imaging scans, and tests of heart function. Participants may also wear a device to monitor their heart rhythms at home.

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 be reduced or abolished by non-surgical catheter procedures to heat and destroy the small portions of the heart that contribute a short circuit or abnormal pacemaker. However, not all portions of the heart can physically be reached for catheter treatment. We have developed a new non-surgical catheter approach called VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) to treat ventricular arrhythmias arising from difficult-to-reach portions of the heart. In VINTAGE, catheter tools are moved inside the walls of the beating heart to reach treatment targets. In a small number of patients who failed prior catheter treatment of ventricular arrhythmia, VINTAGE effectively suppressed the ventricular arrhythmia or abnormal pacemaker in most. The purpose of this research protocol is to test VINTAGE more carefully in people with ventricular arrhythmias who have failed prior catheter ablation. In this protocol, we will use catheter tools that are commercially available but are not designed or approved for use in VINTAGE.

Conditions

• Ventricular Arrhythmia

Interventions

Type	Name	Description
DEVICE	VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms)	Non-surgical catheter approach called VINTAGE will be used to treat ventricular arrhythmias arising from difficult-to-reach portions of the heart.

Timeline

• Start date: 2026-04-22
• Primary completion: 2026-12-01
• Completion: 2027-07-01
• First posted: 2025-04-23
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study