Actively Recruiting
Catheter Ablation Versus Non-Invasive Radio-Ablation for Ventricular Tachycardia Using ECG Mapping: A Randomized Controlled Trial
Led by Ottawa Heart Institute Research Corporation · Updated on 2025-11-20
244
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for Ventricular Tachycardia (VT), comparing the current standard catheter ablation with a novel non-invasive radio-ablation guided by ECG-based body surface mapping. This trial aims to assess if the non-invasive approach can be a safer and effective alternative for patients, especially those at high risk of complications with traditional treatments. The study is a randomized controlled trial sponsored by the Ottawa Heart Institute Research Corporation, focusing on patients aged 55 and older with cardiomyopathy and recurrent VT despite prior catheter ablation or high-risk features. The trial involves two groups: one receiving the standard catheter ablation, which is an invasive procedure using catheters guided by imaging to deliver radiofrequency energy to affected heart tissue, typically lasting around 5 hours under sedation or anesthesia; and the other undergoing a non-invasive radio-ablation. The non-invasive procedure uses ECGi mapping under light sedation to identify VT circuits, followed by a brief 15-minute outpatient radiotherapy treatment targeting those areas. Both methods require pre-treatment imaging and medical stabilization, but the non-invasive group avoids catheter insertion. Participants will have multiple assessments including imaging scans like echocardiography, CT, PET, and ECGi mapping. Researchers will monitor outcomes such as time to composite events within 14 days, ICD therapies, VT episodes, hospital admissions, heart failure events, quality of life, and medication use over a period of up to three years. Safety and treatment effects will be carefully tracked, including any procedural complications or inflammation symptoms after radiotherapy. The study provides ongoing follow-up to understand long-term outcomes for both treatments.
CONDITIONS
Brief Title
Catheter Ablation Versus Radio-Ablation for Ventricular Tachycardia: a Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 55 years or older
- Diagnosis of cardiomyopathy with left ventricular ejection fraction 35% or less and an implanted ICD
- Recurrent ventricular tachycardia despite previous catheter ablation OR VT events needing intervention with a PAINESD score 15 or higher
You will not qualify if you...
- NYHA Class IV heart failure or presence of Left Ventricular Assist Device (LVAD)
- Life expectancy less than one year for any reason
- Prior thoracic radiotherapy
- Participation in another randomized clinical trial
- Unable or unwilling to provide informed consent
- Age 54 years or younger
- Pregnancy or breastfeeding
- Women of childbearing age not using medically acceptable contraception throughout the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session with preparatory imaging and mapping procedures
Participants receive either catheter ablation involving invasive mapping and ablation under sedation or anesthesia, or non-invasive radio-ablation guided by ECGi mapping and multimodal imaging followed by a 15 minute outpatient radiotherapy treatment.
1 to 2 visits depending on treatment arm
Duration - Up to 3 years
Participants are monitored for treatment outcomes including ICD activity, arrhythmia events, quality of life, and potential complications up to 3 years after treatment.
Regular follow-up visits for up to 3 years
Trial Site Locations
Total: 1 location
1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
Research Team
C
Calum Redpath
T
Tammy Knight
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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