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

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ClinicalTrials.gov Identifier: NCT03523286
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
Maritime Heart Centre
Information provided by (Responsible Party):
Amir AbdelWahab, Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Ischemic Heart Disease Other: RAPID-VT Software guided ablation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Real-time Automated Program for IDentification of VT Origin - Pilot Study
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523286


Contacts
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Contact: Amir AbdelWahab, MD 9024735023 amir.abdelwahab@nshealth.ca
Contact: Gillian Schraefel 9024737733 Gillian.Schraefel@nshealth.ca

Locations
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Canada, Nova Scotia
QE II Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Gillian Schraefel    9024737733    Gillian.Schraefel@nshealth.ca   
Sponsors and Collaborators
Amir AbdelWahab
Maritime Heart Centre
Investigators
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Principal Investigator: Amir AbdelWahab Nova Scotia Health Authority

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Responsible Party: Amir AbdelWahab, Attending Cardiac Electrophysiologist, Assistant Professor of Medicine, Division of Cardiology, Department of Medicine, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03523286     History of Changes
Other Study ID Numbers: 6201
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amir AbdelWahab, Nova Scotia Health Authority:
Catheter ablation
ECG imaging
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases