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| Name | Class |
|---|---|
| Maritime Heart Centre | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAPID-VT Software guided ablation | Experimental | The induced VT(s) 12-lead ECG will be acquired by the RAPID-VT software which will provide real time localization of the VT(s) exits from the scar margin. These exits will be targeted by ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAPID-VT Software guided ablation | Other | Catheter ablation will target VT exit sites at scar margin as determined by the RAPID-VT software |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-inducibility of VT | Lack of any inducible VT at the end of the ablation procedure | At end of ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure efficacy measure: VT(s) ablated | Number of VTs identified and targeted with ablation | At end of procedure |
| Procedure efficacy measure: Procedure duration | Duration of procedure in minutes |
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Inclusion Criteria:
Patients will be eligible for inclusion if they fulfilled VANISH inclusion criteria by having both of:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Amir AbdelWahab | Nova Scotia Health Authority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QE II Health Sciences Centre | Halifax | Nova Scotia | B3H 3A7 | Canada |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| At end of procedure |
| Procedure efficacy measure: VT recurrence | Time to recurrence of VT in months | During follow up period of 6 months |
| Procedure safety measure: Acute complications | Incidence of any procedure-related complications | 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 | 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 | At 30 days and 6 months of follow up |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |