Real-time Automated Program for IDentification of VT Origin (RAPIDVTPilot)

Real-time Automated Program for IDentification of VT Origin - Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Disease; Ventricular Tachycardia
• Intervention / Treatment: Other: RAPID-VT Software guided ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • QE II Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Other: RAPID-VT Software guided ablation; Catheter ablation will target VT exit sites at scar margin as determined by the RAPID-VT software

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Amir AbdelWahab
• Collaborators: Maritime Heart Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): November 1, 2021
• Study Completion (ACTUAL): May 1, 2022

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (ACTUAL): May 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Catheter ablation; ECG imaging
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Coronary Disease; Cardiac Conduction System Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: 6201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No