Skip to main content
OpenTrials
Completed

NCT Number: NCT03523286

Real-time Automated Program for IDentification of VT Origin

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QE II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients will be eligible for inclusion if they fulfilled VANISH inclusion criteria by having both of:
  • 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

Exclusion criteria

  • 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.

Treatment and study plan

RAPID-VT Software guided ablation

Other

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

Primary outcomes

  1. Non-inducibility of VT

    Time frame: At end of ablation procedure

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

Secondary outcomes

  1. Procedure efficacy measure: VT(s) ablated

    Time frame: At end of procedure

    Number of VTs identified and targeted with ablation

  2. Procedure efficacy measure: Procedure duration

    Time frame: At end of procedure

    Duration of procedure in minutes

  3. Procedure efficacy measure: VT recurrence

    Time frame: During follow up period of 6 months

    Time to recurrence of VT in months

  4. Procedure safety measure: Acute complications

    Time frame: At end of procedure and at 30 days of follow up

    Incidence of any procedure-related complications

  5. Procedure safety measure: Clinical heart failure worsening

    Time frame: 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

  6. Procedure safety measure: Mortality and hospitalization for cardiac causes

    Time frame: At 30 days and 6 months of follow up

    Death and/or cardiac hospitalization

Sponsors and collaborators

Lead sponsor

Amir AbdelWahab

Other

Collaborators

  • Maritime Heart Centre

Registry information

Official study title

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

Acronym: RAPIDVTPilot

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
May 14, 2018
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.