Real-time Automated Program for IDentification of VT Origin

NCT03523286 | Completed

• 1 other identifier: 6201
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia; Ischemic Heart Disease

Keywords

Catheter ablation; ECG imaging

Outcome Measures

Primary Outcomes (1)

• Non-inducibility of VT

  Lack of any inducible VT at the end of the ablation procedure

  At end of ablation procedure

Secondary Outcomes (6)

• Procedure efficacy measure: VT(s) ablated

  At end of procedure

• Procedure efficacy measure: Procedure duration

  At end of procedure

• Procedure efficacy measure: VT recurrence

  During follow up period of 6 months

• Procedure safety measure: Acute complications

  At end of procedure and at 30 days of follow up

• Procedure safety measure: Clinical heart failure worsening

  At end of procedure, at 30 days and 6 months of follow up

Study Arms (1)

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

Other: RAPID-VT Software guided ablation

Interventions

RAPID-VT Software guided ablation OTHER

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

RAPID-VT Software guided ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)38 and
• 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

You may not qualify if:

• Patients will be excluded from the trial if they:
• Are unable or unwilling to provide informed consent.
• Have active ischemia or another reversible cause of VT (e.g. drug-induced arrhythmia), or had recent acute coronary syndrome requiring revascularization.
• Are antiarrhythmic drug-naïve.
• Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves.
• Have had a prior catheter ablation procedure for VT.
• Are in renal failure (Creatinine clearance \<15 mL/min)
• Have NYHA Functional class IV heart failure or CCS Functional class IV angina.
• Have had recent ST elevation myocardial infarction (\< 1 month).
• Are pregnant or have a systemic illness likely to limit survival to \<1 year.

Sponsors & Collaborators

• Amir AbdelWahab: lead
• Maritime Heart Centre: collaborator

Study Sites (1)

QE II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Amir AbdelWahab

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Cardiac Electrophysiologist, Associate Professor of Medicine, Division of Cardiology, Department of Medicine

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: May 14, 2018
• Study Start: October 1, 2018
• Primary Completion: November 1, 2021
• Study Completion: May 1, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)