Catheter Ablation Versus Radio-Ablation for Ventricular Tachycardia: a Randomized Controlled Trial

NCT05047198 | Recruiting Phase 3 DMC

• 1 other identifier: 06-2021
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two arms - the current standard of care catheter ablation for Ventricular Tachycardia compared to stereotactic radiotherapy to non-invasively ablate ventricular tachycardia using a novel non-invasive ECG based body surface mapping technology. This allows investigators to identify ventricular tachycardia circuits to target for subsequent radio ablation. To summarize, the current standard of care invasive catheter ablation to the non-invasive radio ablation.

Conditions

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• Time to composite event

  Composite event including death at any time, appropriate ICD shock after 14 days, ventricular tachycardia storm after 14 days, treated sustained ventricular tachycardia below the detection rate of the ICD after 14 days

  14 days

Secondary Outcomes (18)

• Appropriate ICD ATP at any time or after 14 days

  at any time or after 14 days

• Appropriate shocks

  at any time or after 14 days

• VT storm at any time or after 14 days

  at any time or after 14 days

• Sustained VT not treated by ICD at any time or after 14 days

  at any time or after 14 days

• Inappropriate ICD shocks at any time or after 14 days

  at any time or after 14 days

Study Arms (2)

Control

ACTIVE COMPARATOR

Catheter Ablation using invasive mapping

Procedure: Control - Catheter Ablation for VT

Treatment

EXPERIMENTAL

Radio-ablation using non-invasive mapping

Procedure: Treatment - Non-Invasive Radio Ablation for VT

Interventions

Control - Catheter Ablation for VT PROCEDURE

Currently standard of care involves surgical resection of myocardial scarring in structural heart disease. Imaging is performed to identify culprit areas for ablation, pre procedural imaging involves echocardiography, CT scanning and PET imaging to assess cardiac function, ischemia, inflammation and scarring. Radiofrequency energy is delivered via catheter to the targets and is performed under sedation or anesthesia using multiple catheters placed in the heart while the patient is anticoagulated. A conventional approach will be used advancing multiple catheters via femoral veins and/or arteries under a combination of fluoroscopic, ultrasound and electroanatomic guidance. Ablation targets include an arrhythmogenic focus or the critical isthmus of the VT circuit and/ or substrate identified on preprocedural imaging or low voltage areas, "scar", identified during endocardial mapping. CA procedures for VT are often long, averaging approximately 5 hours .

Control

Treatment - Non-Invasive Radio Ablation for VT PROCEDURE

Patients undergoing a non-invasive RA procedure for VT similarly require medical stabilization and multimodal imaging prior to treatment. A non-invasive electrophysiology study is performed under light sedation using ECGi mapping. This procedure requires only the placement of an IV cannula for light sedation, uses the ICD to stimulate VT which is mapped in real time using the ECGi mapping system. The multimodal imaging data is digitally fused and combined with the ECGi data to identify the VT circuit(s) and to attain the targets for radio-ablation. This analogue process is performed off-line by a physician team. The treatment plan is sent for alignment on a 4D planning CT performed with breath holding in the radiotherapy suite. Final treatment targets are reviewed by the local treating team and discussed with our collaborators remotely. Thereafter the patient is booked for a 15 minute out-patient radiotherapy treatment performed on a standard linear accelerator.

Treatment

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged ≥55 years of age
• Cardiomyopathy (Left ventricular ejection fraction ≤ 35% and ICD in situ) AND
• Recurrent VT events despite previous CA OR
• VT events requiring intervention and PAINESD score ≥ 15

You may not qualify if:

• Patients with NYHA Class IV heart failure \&/ or with LVAD in situ
• Patients not expected to live for more than one year for any reason
• Patients who have previously received thoracic radiotherapy
• Patients who are enrolled in another randomized clinical trial
• Patients who are unable or unwilling to provide informed consent
• Patients aged ≤54 years of age
• Pregnancy (all women of child bearing age and potential will have a negative β-HCG test before enrollment)
• Breastfeeding
• Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception (IUD, sterilization, birth control implant or birth control pill) throughout the study.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Calum Redpath

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Calum Redpath

CONTACT

6136967000; credpath@ottawaheart.ca

Tammy Knight

CONTACT

6136967000; tknight@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, vanguard non-inferiority, randomized controlled trial

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 17, 2021
• Study Start: December 6, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 15, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)