Non-invasive Mapping-guided Ablation of VT

Ventricular Tachycardia Clinical Trial

— NoMo-VT  

Official title:

Computational Cardiac Mapping Techniques to Guide Ablation of Arrhythmogenic Substrate Underlying Ventricular Tachycardia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06464315
• Other study ID #: CARA-007-23F
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: September 30, 2028

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: Gordon Ho, MD
• Phone: (858) 642-3147
• Email: Gordon.Ho[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 a new non-invasive targeting tool can help guide doctors during the procedure and improve the outcomes of the ablation procedure. Once this study is completed, the investigators will know whether this tool could help increase the efficacy, safety and accuracy of ablation therapy of fatal heart rhythms.

Description:

Ventricular tachycardia (VT) remains a leading cause of death and morbidity in the Veteran population, but current ablation procedures to treat VT are limited by high VT recurrence rates up to 60%, lengthy invasive procedures, and invasive risks and difficulty in accurately localizing all the critical arrhythmogenic sites sustaining VT. The long-term goal is to harness the power of computational modeling to improve the efficacy, efficiency and safety of VT catheter ablation. The overall objective of this study is to perform a randomized clinical trial to see if the incorporation of computational ECG mapping guidance during VT ablation improves clinical outcomes of VT recurrence and ablation efficiency. The central hypothesis is that use of forward solution computational ECG mapping can improve clinical outcomes of VT ablation by localizing VT origins located in arrhythmogenic myocardial substrate that are critical in sustaining VT. The rationale is that novel non-invasive ECG mapping may be able to overcome the challenges of conventional invasive mapping techniques and improve the low success rates of VT ablation. The central hypothesis will be tested by pursuing one primary specific aim: Perform a randomized clinical trial to determine whether the use of computational ECG analysis during VT ablation can 1) reduce recurrent VT and 2) decrease intra-procedural mapping time, fluoroscopy time, and number of invasive access sites. This randomized clinical trial will test whether a VT ablation strategy incorporating computational mapping will improve efficiency and freedom from VT compared to standard-of-care ablation. The research proposed is innovative because it tests the ability of a novel computational analysis technique developed by the investigators' lab to guide ablation of critical arrhythmogenic tissue underlying VT. The proposed research is significant because it is expected to translate novel computational techniques and rigorously test its ability to improve the efficacy and efficiency of a complex ablation procedure to treat a fatal heart rhythm disorder.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: September 30, 2028
• Est. primary completion date: March 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Men and women >18 years of age referred for clinically indicated ventricular tachycardia (VT) ablation and experience monomorphic or polymorphic VT documented by telemetry, implantable cardioverter-defibrillator (ICD) interrogation, electrocardiogram (ECG) or event monitoring

• Patients deemed to be high risk for acute hemodynamic decompensation (PAINESD score >15) and require prophylactic temporary mechanical support (intra-aortic balloon pump, Impella, TandemHeart, or veno-arterial extra-corporeal membrane oxygenation support (VA ECMO) will also be included

• Patients undergoing epicardial VT ablation will also be included

Exclusion Criteria:

• Patients who are pregnant

• Presence of intracardiac thrombus

• active acute coronary syndrome with unrevascularized coronary artery disease (CAD)

• Active bacteremia

• Inaccessible ventricles due to dual mechanical valves

• Inability to tolerate and inability to tolerate anticoagulation during ablation and for at least 1 month after ablation

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Sudden Cardiac Death
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Computerized ECG Mapping
Non-invasive localization of ventricular tachycardia using computerized analysis of 12-lead ECG with visualization on a 3D model to help guide physicians perform VT ablation. Cleared by the FDA.

Diagnostic Test:
• Standard-of-Care Mapping/Imaging
Only conventional invasive and non-invasive mapping and cardiac imaging techniques will be used to guide VT ablation.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

Fox SR, Toomu A, Gu K, Kang J, Sung K, Han FT, Hoffmayer KS, Hsu JC, Raissi F, Feld GK, McCulloch AD, Ho G, Krummen DE. Impact of artificial intelligence arrhythmia mapping on time to first ablation, procedure duration, and fluoroscopy use. J Cardiovasc Electrophysiol. 2024 May;35(5):916-928. doi: 10.1111/jce.16237. Epub 2024 Mar 4. — View Citation

Krummen DE, Villongco CT, Ho G, Schricker AA, Field ME, Sung K, Kacena KA, Martinson MS, Hoffmayer KS, Hsu JC, Raissi F, Feld GK, McCulloch AD, Han FT. Forward-Solution Noninvasive Computational Arrhythmia Mapping: The VMAP Study. Circ Arrhythm Electrophysiol. 2022 Sep;15(9):e010857. doi: 10.1161/CIRCEP.122.010857. Epub 2022 Sep 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	total procedural time	time from introduction of catheters to removal of catheters	immediately at the end of the procedure
Other	Procedural adverse events or complications	Major complications include: new acute pericardial effusion requiring intervention, vascular complication requiring intervention, embolic stroke confirmed by brain imaging, limb ischemia requiring intervention, or bacteremia.; Major adverse events include: cardiogenic shock (requiring escalation of inotropes or salvage mechanical circulatory support)	1 month
Other	Number of vascular access sites	Total number of sheaths inserted into the femoral veins and arteries	immediately at the end of the procedure
Other	Total fluoroscopy time	Total amount of fluoroscopy time during the entire procedure	immediately at the end of the procedure
Primary	Time to composite endpoint (VT recurrence or death)	Time to composite endpoint of VT recurrence (determined by ICD shock) or any death	6 months
Secondary	VT burden (ICD therapy including shocks and ATP, sustained VT episodes >30 seconds)	Total number of ICD therapies (ATP and shocks) and recorded sustained VT episodes>30 seconds, compared 6 months before and 6 months after ablation.	6 months
Secondary	Total Mapping Time	time from introduction of catheters to first ablation lesion	immediately at the end of the procedure