RecruitingPhase 3NCT05047198

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


Sponsor

Ottawa Heart Institute Research Corporation

Enrollment

244 participants

Start Date

Dec 6, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 55 Years

Inclusion Criteria4

  • 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

Exclusion Criteria9

  • 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.

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Interventions

PROCEDUREControl - Catheter Ablation for VT

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 .

PROCEDURETreatment - Non-Invasive Radio Ablation for VT

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.


Locations(1)

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

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NCT05047198


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