Clinical trial NCT03523286: Real-time Automated Program for IDentification of VT Origin
Official title: Real-time Automated Program for IDentification of VT Origin - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Ischemic Heart Disease
Keywords: Catheter ablation
ECG imaging
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Maritime Heart Centre
First posted: 2018-05-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Non-inducibility of VT
timeFrame: At end of ablation procedure
Secondary outcomes:
measure: Procedure efficacy measure: VT(s) ablated
timeFrame: At end of procedure
measure: Procedure efficacy measure: Procedure duration
timeFrame: At end of procedure
measure: Procedure efficacy measure: VT recurrence
timeFrame: During follow up period of 6 months
measure: Procedure safety measure: Acute complications
timeFrame: At end of procedure and at 30 days of follow up
measure: Procedure safety measure: Clinical heart failure worsening
timeFrame: At end of procedure, at 30 days and 6 months of follow up
measure: Procedure safety measure: Mortality and hospitalization for cardiac causes
timeFrame: At 30 days and 6 months of follow up
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QE II Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Amir AbdelWahab
role: PRINCIPAL_INVESTIGATOR
References: