Comparing catheter ablation and non-invasive radio ablation for ventricular tachycardia
Catheter Ablation Versus Radio-Ablation for Ventricular Tachycardia: a Randomized Controlled Trial
This study is testing a new non-invasive treatment for ventricular tachycardia to see if it works better and is safer than the standard catheter ablation for older patients who have had repeated issues.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 244 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT05047198 on ClinicalTrials.gov |
What this trial studies
This study compares two treatment methods for ventricular tachycardia: the standard catheter ablation and a novel non-invasive radio ablation technique using ECG-based body surface mapping. The goal is to determine the effectiveness of non-invasive radio ablation in targeting and treating ventricular tachycardia circuits without the complications associated with invasive procedures. Patients aged 55 and older with recurrent VT despite previous treatments will be enrolled. The study aims to provide a safer alternative for patients at high risk of complications from traditional catheter ablation.
Who should consider this trial
Good fit: Ideal candidates are patients aged 55 and older with cardiomyopathy and recurrent ventricular tachycardia events despite previous catheter ablation.
Not a fit: Patients with advanced heart failure, those not expected to live for more than one year, or those who have previously received thoracic radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a less invasive and safer treatment option for patients suffering from recurrent ventricular tachycardia.
How similar studies have performed: While catheter ablation is the current gold standard, the non-invasive radio ablation approach is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient aged ≥55 years of age 2. Cardiomyopathy (Left ventricular ejection fraction ≤ 35% and ICD in situ) AND 3. Recurrent VT events despite previous CA OR 4. VT events requiring intervention and PAINESD score ≥ 15 Exclusion Criteria: 1. Patients with NYHA Class IV heart failure \&/ or with LVAD in situ 2. Patients not expected to live for more than one year for any reason 3. Patients who have previously received thoracic radiotherapy 4. Patients who are enrolled in another randomized clinical trial 5. Patients who are unable or unwilling to provide informed consent 6. Patients aged ≤54 years of age 7. Pregnancy (all women of child bearing age and potential will have a negative β-HCG test before enrollment) 8. Breastfeeding 9. 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.
Where this trial is running
Ottawa, Ontario
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Calum Redpath — Ottawa Heart Institute Research Corporation
- Study coordinator: Calum Redpath
- Email: credpath@ottawaheart.ca
- Phone: 6136967000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.