Non-Invasive Mapping-Guided Ablation for Rapid Heartbeat

(NoMoVT Trial)

Overseen By Nicholas W Wettersten, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Pregnancy, Intracardiac thrombus, Coronary ischemia, others

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

Compensation: Varies

Number of Visits: 1

Duration: 8 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat ventricular tachycardia (VT), a condition where the heart beats too fast, by using a non-invasive mapping technique to guide ablation, a procedure that destroys harmful heart tissue. The study compares two approaches: the standard method, which involves inducing VT to locate problem areas, and an experimental method that targets areas of slow conduction without inducing VT. The researchers aim to determine if the experimental method is safer and more effective. Individuals with heart disease-related VT who are already planning to undergo an ablation procedure may be suitable candidates for this trial. As an unphased trial, this study allows patients to contribute to innovative research that could lead to safer and more effective VT treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify if 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 this non-invasive mapping-guided ablation is safe for ventricular tachycardia treatment?

Research has shown that a new method called non-invasive mapping-guided ablation might be safer for patients. This technique targets specific areas of the heart without causing ventricular tachycardia (VT). One study found that this method achieved similar results in preventing VT recurrence and avoiding heart transplants or death, compared to older methods that induce VT. Safety remains a major concern, and previous studies have used imaging to monitor any issues. Reports suggest that patients tolerated the procedure well, with no major side effects. This method is still under investigation, so while early results are promising, more information is needed to fully understand its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the non-invasive mapping-guided ablation technique because it offers a new way to treat rapid heartbeats, or ventricular tachycardia (VT), without the need for standard VT induction protocols. Traditional treatments often rely on inducing VT to map and treat arrhythmias, but this method focuses on identifying and ablating regions of slow conduction using advanced mapping techniques. This includes detecting areas with deceleration zones, wavefront discontinuities, and high peak frequency signals, which are indicators of slow conduction. By targeting these specific regions, the technique aims to provide a more precise and potentially safer treatment option for patients with VT.

What evidence suggests that this trial's treatments could be effective for ventricular tachycardia?

This trial compares two approaches for guiding ablation in patients with ventricular tachycardia (VT). In one arm, participants receive standard VT mapping, which includes voltage mapping of intrinsic rhythm and other techniques to guide ablation. In the experimental arm, participants undergo non-invasive mapping-guided ablation, focusing on areas with slow heart signals without triggering VT. Research has shown that this non-invasive method can be effective. Studies have found that focusing on areas with slow heart signals, without triggering VT, can lower the chance of VT recurrence. For instance, one study found that not triggering VT did not lead to more cases of VT returning, needing a heart transplant, or death compared to traditional methods. Another study showed that non-invasive techniques could accurately identify problem areas in the heart that cause VT. These findings suggest that this approach might make VT treatments safer and more successful. ^{1 2 3 4 6}

Who Is on the Research Team?

Gordon Ho, MD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for individuals with a condition called ventricular tachycardia, which causes rapid heartbeat and can lead to sudden cardiac death. Participants should be candidates for an ablation procedure to destroy diseased heart tissue.

Inclusion Criteria

I am at high risk for sudden heart function worsening and need a device to help my heart.

I am undergoing or have undergone an epicardial VT ablation.

Exclusion Criteria

Patients who are pregnant

I have untreated coronary artery disease.

I cannot tolerate blood thinners during and for a month after ablation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo VT ablation guided by either standard VT mapping or functional substrate mapping without VT induction

8 hours

1 visit (in-person)

Follow-up

Participants are monitored for VT recurrence, death, or acute hemodynamic decompensation

6 months

Long-term follow-up

Participants are monitored for VT burden and procedural adverse events

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Non-invasive Mapping-guided Ablation

Trial Overview The study is testing a new non-invasive tool that guides doctors during heart ablation procedures against the standard mapping/imaging techniques. The goal is to see if this tool improves the success rate and safety of treatments.

How Is the Trial Designed?

Group I: Functional substrate mapping only without VT induction Experimental Treatment 1 Intervention

In this experimental arm, only functional substrate mapping will be used to guide ablation of conduction slowing regions, without VT induction or mapping during VT. Ablation targets of conduction slowing will be identified as: 1) deceleration zones of conduction slowing, previously defined as 3 isochrones coalescing within 1cm radius. 2) wavefront discontinuities represented by lines of conduction block, previously defined as late potentials with at least 20ms of isoelectric segment, and 3) regions of slow conduction characterized by high peak frequency (220-500Hz), which uses spectral frequency analysis to identify signals with highest frequency as a surrogate for slow conduction. All regions exhibiting any of these 3 surrogates of slow conduction will be ablated.

Group II: Standard VT Mapping Active Control 1 Intervention

Standard-of-care mapping, including voltage mapping of intrinsic rhythm, entrainment, activation, and/or pace mapping, will be performed to guide VT ablation. Standard VT induction protocols will be performed.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study of 883 patients undergoing radiofrequency ablation for atrial flutter, 5% experienced adverse events (AEs), with 14 cases being life-threatening, highlighting the need for careful monitoring during the procedure.

Most AEs were linked to the use of rate-control medications, particularly in females and those with heart disease, suggesting that better management of anticoagulants and medications could reduce the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is ablation of atrial flutter always safe? Brembilla-Perrot, B., Filali, ML., Zinzius, PY., et al.[2012]

Citations

1. withpower.com withpower.com/trial/phase-tachycardia-9-2024-f6d59

Non-Invasive Mapping-Guided Ablation for Rapid Heartbeat This study will test to see if an experimental strategy of only targeting regions of slow conduction without the induction of VT can improve the efficacy and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10240275/

Successful Noninvasive 12-Lead ECG Mapping-Guided ... Successful Noninvasive 12-Lead ECG Mapping-Guided Radiotherapy of Inaccessible Ventricular Tachycardia Substrate Due to Mechanical Valves.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1613773

Noninvasive Cardiac Radiation for Ablation of Ventricular ... We combined these techniques to perform catheter-free, electrophysiology-guided, noninvasive cardiac radioablation for ventricular tachycardia.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666501824003738

Clinical outcomes after ventricular tachycardia ablation ... A strategy of avoiding VT induction vs attempting VT induction resulted in a similar incidence of VT recurrence, heart transplant, or death at 1 year.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4067940/

Noninvasive electrocardiographic mapping to guide ... ECG algorithms identified the correct chamber of origin in 50%–88% of the patients and sublocalized within the right ventricular outflow tract (septum vs free- ...

6. jacc.org jacc.org/doi/10.1016/j.jacep.2020.07.028

Safety and Outcomes of Ventricular Tachycardia Substrate ... This study sought to analyze safety and outcomes of ventricular tachycardia (VT) substrate ablation during sinus rhythm (SR), without baseline VT induction.