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

36 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Non-invasive Mapping-guided Ablation for rapid heartbeat?

Research shows that non-contact mapping techniques, which are part of the non-invasive mapping-guided ablation, have been effective in guiding ablation for various heart rhythm issues, like ventricular tachycardia and inappropriate sinus tachycardia, improving patient outcomes. ^{1 2 3 4 5}

Is non-invasive mapping-guided ablation generally safe for humans?

Studies show that non-invasive mapping-guided ablation, including systems like ultra-high density and non-contact mapping, is generally considered safe for treating heart rhythm issues, with improvements in safety due to reduced radiation exposure and detailed heart mapping. ^{6 7 8 9 10}

How does non-invasive mapping-guided ablation differ from other treatments for rapid heartbeat?

Non-invasive mapping-guided ablation is unique because it uses a non-contact mapping system to create a 3D map of the heart's electrical activity, allowing precise targeting of abnormal areas causing rapid heartbeat. This method is less invasive than traditional catheter ablation and can be performed without direct contact with the heart tissue, potentially reducing risks and improving accuracy. ^{2 11 12 13 14}

What is the purpose of this trial?

Ventricular tachycardia (VT) is a leading cause of death and suffering in the Veteran population. Currently, ablation procedures are performed to destroy the diseased tissue that causes this problem. 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 safety of VT ablation. Once this study is completed, the investigators will know whether this ablation strategy could help increase the efficacy, safety and efficiency of ablation therapy of fatal heart rhythms.

Research Team

Gordon Ho, MD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

A novel method for nonfluoroscopic catheter-based electroanatomical mapping of the heart. In vitro and in vivo accuracy results. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Noncontact endocardial mapping to guide ablation for hemodynamically unstable or nonsustained ventricular tachycardia]. [2011]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Radiofrequency catheter ablation using non-contact mapping for inappropriate sinus tachycardia. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Clinical utility of non-contact charge density 'SuperMap' algorithm for the mapping and ablation of organized atrial arrhythmias. [2022]

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

Quantitative evaluation of different high-density 3D mapping modes for atrial and ventricular substrate assessment of cardiac arrhythmias with the HD grid catheter. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Acute safety, effectiveness, and real-world clinical usage of ultra-high density mapping for ablation of cardiac arrhythmias: results of the TRUE HD study. [2020]

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

Noncontact mapping of the heart: how and when to use. [2009]

8. Spain pubmed.ncbi.nlm.nih.gov

[Non-fluoroscopic electroanatomical mapping (CARTO system) in the ablation of atrial tachycardias]. [2006]

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

Is ablation of atrial flutter always safe? [2012]

10. Japan pubmed.ncbi.nlm.nih.gov

Three-dimensional mapping of cardiac arrhythmias - string of pearls - . [2019]

11. Japan pubmed.ncbi.nlm.nih.gov

Radiofrequency catheter ablation of various kinds of arrhythmias guided by virtual electrograms using a noncontact, computerized mapping system. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

[Non-contact mapping: a simultaneous spatial detection in the diagnosis of arrhythmias]. [2007]

13. Singapore pubmed.ncbi.nlm.nih.gov

New directions in cardiovascular mapping and therapy. [2020]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Circle Method for Robust Estimation of Local Conduction Velocity High-Density Maps From Optical Mapping Data: Characterization of Radiofrequency Ablation Sites. [2022]