RAPID-VT Pilot is a single centre prospective cohort pilot study to assess the feasibility, safety and efficacy of catheter ablation of ventricular tachycardia (VT) guided by a novel real-time software to localize the origin of VT during the ablation procedure.
Consecutive patients with ischemic heart disease and clinical indication of VT ablation will undergo baseline clinical evaluation, echocardiography and cardiac CT imaging using a contrast-enhanced cardiac-gated method with a 64-section scanner. Trans-axial CT images comprising the whole heart volume will be exported in DICOM format. CT image processing will be performed and will be used to delineate the LV endocardial and/or epicardial geometries. These data will be imported into the RAPID-VT software and the 3D-electranatomical mapping system for image integration. During the VT ablation procedure, VT(s) induction will be performed. The VT(s) 12-lead ECG will be acquired by the RAPID-VT software and will be localized to the scar margin using the RAPID-VT software. Catheter ablation will be attempted at software-determined sites. Post procedure, patient will be followed up for a minimum of 6 months. That will include Remote ICD follow-up and telephone study visits. Follow-up at 6 months will include a clinic visit for assessment of heart failure status, ECG, ICD interrogation and changes in antiarrhythmic drug therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Catheter ablation will target VT exit sites at scar margin as determined by the RAPID-VT software
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada
Non-inducibility of VT
Lack of any inducible VT at the end of the ablation procedure
Time frame: At end of ablation procedure
Procedure efficacy measure: VT(s) ablated
Number of VTs identified and targeted with ablation
Time frame: At end of procedure
Procedure efficacy measure: Procedure duration
Duration of procedure in minutes
Time frame: At end of procedure
Procedure efficacy measure: VT recurrence
Time to recurrence of VT in months
Time frame: During follow up period of 6 months
Procedure safety measure: Acute complications
Incidence of any procedure-related complications
Time frame: At end of procedure and at 30 days of follow up
Procedure safety measure: Clinical heart failure worsening
Worsening of heart failure symptoms as defined as decline in NYHA Functional class or 6-MWT
Time frame: At end of procedure, at 30 days and 6 months of follow up
Procedure safety measure: Mortality and hospitalization for cardiac causes
Death and/or cardiac hospitalization
Time frame: At 30 days and 6 months of follow up
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