VINTAGE Procedure for Ventricular Arrhythmia

Overseen By Robert J Lederman, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Must be taking: Antiarrhythmics

Disqualifiers: Pregnant, Renal failure, Hemodynamic instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

30 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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. ^{2 3 4 9 10}

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

Willing to return for all scheduled follow-up activities, and eligible or able to undergo required protocol and testing

I have never had heart surgery.

I am scheduled for another heart rhythm correction procedure after the first one and medication didn't work.

Exclusion Criteria

Left ventricular ejection fraction < 0.20

Pregnant

Survival despite successful procedure expected < 6 mo

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants will have baseline tests including blood tests, heart function tests, imaging scans, and a health questionnaire

1 week

1 visit (in-person)

VINTAGE Procedure

Participants will undergo the VINTAGE procedure with catheter insertion through large blood vessels to perform ablation

1-2 days

Hospital stay of 1 or more nights

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

6 months

3 visits (in-person)

Treatment Details

Interventions

• VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms)

Trial Overview The VINTAGE procedure is being tested, where special catheters are navigated inside the heart walls to target and treat the small zones causing irregular heartbeats. This study uses existing commercial catheters in a novel way for this purpose.

Participant Groups

Group I: VINTAGE Arm Experimental Treatment 1 Intervention

Non-surgical catheter approach called VINTAGE will be used to treat ventricular arrhythmias arising from difficult-to-reach portions of the heart.

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Ablation of ventricular tachycardia in 2021. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Electrocardiographic Localization of Ventricular Tachycardia in Patients with Structural Heart Disease. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Catheter ablation of recurrent scar-related ventricular tachycardia using electroanatomical mapping and irrigated ablation technology: results of the prospective multicenter Euro-VT-study. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Correlation of scar in cardiac MRI and high-resolution contact mapping of left ventricle in a chronic infarct model. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cryoablation of ventricular tachycardia guided by return cycle mapping after entrainment. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Catheter Ablation of Ischemic Ventricular Tachycardia With Remote Magnetic Navigation: STOP-VT Multicenter Trial. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Human histopathology of electroanatomic mapping after cooled-tip radiofrequency ablation to treat ventricular tachycardia in remote myocardial infarction. [2005]

8. Netherlands pubmed.ncbi.nlm.nih.gov

MAGNETIC VT study: a prospective, multicenter, post-market randomized controlled trial comparing VT ablation outcomes using remote magnetic navigation-guided substrate mapping and ablation versus manual approach in a low LVEF population. [2018]

9. Italy pubmed.ncbi.nlm.nih.gov

Ventricular tachycardia ablation. [2005]

10. Spain pubmed.ncbi.nlm.nih.gov

[Ventricular tachycardia ablation guided by LocaLisa system in patients with structural heart disease]. [2006]