VINTAGE Procedure for Ventricular Arrhythmia
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the VINTAGE treatment for ventricular arrhythmia?
The VINTAGE treatment, which involves using electrograms to guide ablation, is supported by research showing that similar techniques, like electroanatomical mapping and high-resolution contact mapping, are effective in treating ventricular tachycardia (a type of fast heart rhythm) by accurately targeting and treating the areas of the heart responsible for the arrhythmia.12345
Is the VINTAGE procedure for ventricular arrhythmia safe for humans?
The studies mention the use of catheter ablation, a similar procedure, which has been evaluated for safety in treating ventricular tachycardia (a type of fast heart rhythm) after a heart attack. These studies suggest that catheter ablation is generally considered safe, although it is a complex procedure.23678
What makes the VINTAGE treatment for ventricular arrhythmia unique?
The VINTAGE treatment is unique because it uses a novel approach called Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms, which focuses on precise mapping and targeting of arrhythmogenic areas within the heart. This method aims to improve the accuracy and effectiveness of ablation procedures by using advanced electrogram guidance, potentially offering better outcomes compared to traditional techniques.234910
What is the purpose of this trial?
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.
Research Team
Robert J Lederman, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria
This trial is for individuals with ventricular arrhythmias who have not had success with previous catheter ablation treatments. It's designed to test a new non-surgical catheter technique called VINTAGE, which aims to treat heart rhythm issues from hard-to-reach areas.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Testing
Participants will have baseline tests including blood tests, heart function tests, imaging scans, and a health questionnaire
VINTAGE Procedure
Participants will undergo the VINTAGE procedure with catheter insertion through large blood vessels to perform ablation
Follow-up
Participants will have 3 follow-up visits over 6 months for standard care after heart ablation, including blood tests, imaging scans, and heart function tests
Treatment Details
Interventions
- VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms)
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Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor