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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure called VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) to treat ventricular arrhythmia, a condition where the lower part of the heart beats abnormally. VINTAGE aims to improve treatment by reaching difficult parts of the heart that standard methods can't easily access. Suitable candidates have ventricular arrhythmia that hasn't improved with previous ablation (a procedure using heat to correct abnormal heart rhythms) and experience symptoms like severe palpitations or fatigue. Participants will undergo the VINTAGE procedure and attend follow-up visits to monitor their heart health. As an unphased trial, this study offers a unique opportunity to explore a novel procedure that could significantly enhance treatment options for ventricular arrhythmia.

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 prior data suggests that the VINTAGE procedure is safe for treating ventricular arrhythmia?

Research has shown that the VINTAGE procedure could safely treat irregular heartbeats. This non-surgical method reaches hard-to-access areas of the heart with fewer complications. Studies found it to be safe, with few reports of serious side effects, indicating that most patients tolerate it well. However, as with any medical procedure, individual experiences can vary. Discuss potential risks with a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for ventricular arrhythmia involve medication or surgical interventions like catheter ablation, which can be challenging when the arrhythmia arises from hard-to-reach areas of the heart. But the VINTAGE procedure stands out because it uses a non-surgical catheter approach guided by electrograms to precisely target and treat these difficult-to-reach areas. This new method could potentially offer a more precise and less invasive option compared to traditional ablation techniques. Researchers are excited about VINTAGE because it promises to improve the effectiveness and safety of treating ventricular arrhythmias, especially in cases where current options fall short.

What evidence suggests that the VINTAGE procedure is effective for ventricular arrhythmia?

Studies have shown that the VINTAGE procedure, which participants in this trial will undergo, effectively treats irregular heartbeats known as ventricular arrhythmias. This method employs a special technique to reach and treat heart areas typically inaccessible with traditional tools. Research indicates that VINTAGE can successfully create small scars in these difficult-to-reach areas to block abnormal electrical signals. Initial findings suggest that this approach could be safer and more effective for patients whose conditions did not improve with standard treatments. Overall, promising evidence supports VINTAGE as a new option for managing challenging cases of ventricular arrhythmia. ^{1 2 3 4 6}

Who Is on the Research Team?

Robert J Lederman, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40704960/

Ventricular Intramyocardial Navigation for Tachycardia ... Conclusions: VINTAGE was effective at creating intramural ablation lesions and treating ventricular arrhythmias arising from targets ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405500X24002676

Ventricular Intramyocardial Navigation for Tachycardia ... VINTAGE was safe and effective at creating intramural ablation lesions in targets traditionally considered inaccessible from the endocardium and epicardium.

3. jacc.org jacc.org/doi/abs/10.1016/j.jacep.2025.06.003

Initial Human Experience | JACC: Clinical Electrophysiology VINTAGE was effective at creating intramural ablation lesions and treating ventricular arrhythmias arising from targets traditionally considered inaccessible ...

4. heartrhythmcasereports.com heartrhythmcasereports.com/article/S2214-0271(24)00295-1/fulltext

Ventricular intramyocardial navigation for tachycardia ... We have developed ventricular intramyocardial navigation for tachycardia ablation by electrograms (VINTAGE), a novel intramyocardial ablation technique.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06940752

Study Details | NCT06940752 | VINTAGE (Ventricular ... Non-surgical catheter approach called VINTAGE will be used to treat ventricular arrhythmias arising from difficult-to-reach portions of the heart. Intervention/ ...

6. jacc.org jacc.org/doi/10.1016/j.jacep.2024.04.002

Deep Ablation in Inaccessible Targets - JACC VINTAGE was safe and effective at creating intramural ablation lesions in targets traditionally considered inaccessible from the endocardium and epicardium.