Real-time Automated Program for IDentification of VT Origin

Ischemic Heart Disease Clinical Trial

— RAPIDVTPilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03523286
• Other study ID #: 6201
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: May 1, 2022

Study information

• Verified date: February 2023
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Other:
• RAPID-VT Software guided ablation
Catheter ablation will target VT exit sites at scar margin as determined by the RAPID-VT software

Locations

Country	Name	City	State
Canada	QE II Health Sciences Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Amir AbdelWahab	Maritime Heart Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inducibility of VT	Lack of any inducible VT at the end of the ablation procedure	At end of ablation procedure
Secondary	Procedure efficacy measure: VT(s) ablated	Number of VTs identified and targeted with ablation	At end of procedure
Secondary	Procedure efficacy measure: Procedure duration	Duration of procedure in minutes	At end of procedure
Secondary	Procedure efficacy measure: VT recurrence	Time to recurrence of VT in months	During follow up period of 6 months
Secondary	Procedure safety measure: Acute complications	Incidence of any procedure-related complications	At end of procedure and at 30 days of follow up
Secondary	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
Secondary	Procedure safety measure: Mortality and hospitalization for cardiac causes	Death and/or cardiac hospitalization	At 30 days and 6 months of follow up