Ischemic Heart Disease, Ventricular Tachycardia
Conditions
Keywords
Catheter ablation, ECG imaging
Brief summary
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.
Detailed description
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.
Interventions
OTHERRAPID-VT Software guided ablation
Catheter ablation will target VT exit sites at scar margin as determined by the RAPID-VT software
Sponsors
Maritime Heart Centre
Amir AbdelWahab
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients will be eligible for inclusion if they fulfilled VANISH inclusion criteria by having both of: 1. Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)38 and 2. One of the following VT events within the last 6 months while on Amiodarone or another class III or class I antiarrhythmic drug: A: Sustained monomorphic VT documented on 12-lead ECG or rhythm strip requiring termination by pharmacologic means or DC cardioversion, B: ≥3 episodes of symptomatic VT treated with anti-tachycardia pacing (ATP), C: ≥1 appropriate ICD shocks, D: ≥3 VT episodes within 24 hours, separated by ≥ 5 minutes, E: sustained VT below detection rate of an ICD
Exclusion criteria
* Patients will be excluded from the trial if they: 1. Are unable or unwilling to provide informed consent. 2. Have active ischemia or another reversible cause of VT (e.g. drug-induced arrhythmia), or had recent acute coronary syndrome requiring revascularization. 3. Are antiarrhythmic drug-naïve. 4. Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves. 5. Have had a prior catheter ablation procedure for VT. 6. Are in renal failure (Creatinine clearance \<15 mL/min) 7. Have NYHA Functional class IV heart failure or CCS Functional class IV angina. 8. Have had recent ST elevation myocardial infarction (\< 1 month). 9. Are pregnant or have a systemic illness likely to limit survival to \<1 year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-inducibility of VT | At end of ablation procedure | Lack of any inducible VT at the end of the ablation procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure efficacy measure: Procedure duration | At end of procedure | Duration of procedure in minutes |
| Procedure efficacy measure: VT recurrence | During follow up period of 6 months | Time to recurrence of VT in months |
| Procedure efficacy measure: VT(s) ablated | At end of procedure | Number of VTs identified and targeted with ablation |
| Procedure safety measure: Clinical heart failure worsening | At end of procedure, at 30 days and 6 months of follow up | Worsening of heart failure symptoms as defined as decline in NYHA Functional class or 6-MWT |
| Procedure safety measure: Mortality and hospitalization for cardiac causes | At 30 days and 6 months of follow up | Death and/or cardiac hospitalization |
| Procedure safety measure: Acute complications | At end of procedure and at 30 days of follow up | Incidence of any procedure-related complications |
Countries
Canada
Outcome results
None listed