NCT05047198 Catheter Ablation Versus Radio-Ablation for Ventricular Tachycardia: a Randomized Controlled Trial
| NCT ID | NCT05047198 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Ventricular Tachycardia |
| Study Type | INTERVENTIONAL |
| Enrollment | 244 participants |
| Start Date | 2022-12-06 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 244 participants in total. It began in 2022-12-06 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Calum Redpath
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT05047198 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Ventricular Tachycardia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05047198 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 244 participants.
Is NCT05047198 currently recruiting?
Yes, NCT05047198 is actively recruiting participants. Contact the research team at credpath@ottawaheart.ca for enrollment information.
Where is the NCT05047198 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT05047198 clinical trial?
NCT05047198 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Calum Redpath at Ottawa Heart Institute Research Corporation. The trial plans to enroll 244 participants.