Real-time Automated Program for IDentification of VT Origin

NCT ID: NCT03523286

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2022-05-01

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.

Conditions

Ventricular Tachycardia; Ischemic Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RAPID-VT Software guided ablation

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

Group Type: EXPERIMENTAL

RAPID-VT Software guided ablation

Intervention Type: OTHER

Catheter ablation will target VT exit sites at scar margin as determined by the RAPID-VT software

Interventions

RAPID-VT Software guided ablation

Catheter ablation will target VT exit sites at scar margin as determined by the RAPID-VT software

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maritime Heart Centre

OTHER

Sponsor Role: collaborator

Amir AbdelWahab

OTHER

Sponsor Role: lead

Responsible Party

Amir AbdelWahab

Attending Cardiac Electrophysiologist, Associate Professor of Medicine, Division of Cardiology, Department of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amir AbdelWahab

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Locations

QE II Health Sciences Centre

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

6201

Identifier Type: -

Identifier Source: org_study_id