Paced Electrogram Feature Analysis (PEFA) for Ablation Targeting in Ischaemic Ventricular Tachycardia (PEFA-VT)
Primary Purpose
Ischemic Ventricular Tachycardia (VT)
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PEFA VT ablation technique
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Ventricular Tachycardia (VT)
Eligibility Criteria
Inclusion Criteria:
- greater than 18 years of age
- Ischaemic heart disease and prior myocardial infarction (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause with documentation of prior ischaemic injury)
- Eligible for catheter ablation as standard of care
- Implantable Cardioverter Defibrillator
Exclusion Criteria:
- Unable or unwilling to provide consent
- Both mechanical aortic and mitral valve
- LV thrombus,
- NYHA class IV heart failure symptoms
- Contraindication to heparin
- Survival limited to <1 year in estimation of attending care team,
- Prior VT ablation Exclusion to standard of care VT catheter ablation procedure such as
- Active ischaemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug- induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia.
- Non-ischaemic cardiomyopathy because of reduced ablation success and PEFA has not been examined in the context of a non-ischaemic cardiomyopathy
Sites / Locations
- Kingston Health Sciences CentreRecruiting
- London Health Sciences Centre
- University of Ottawa Heart Institutation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEFA targeted substrate ablation
Arm Description
Use of PEFA strategy to identify and target VT isthmuses.
Outcomes
Primary Outcome Measures
All-cause mortality
a composite of death - any time post procedure myocardial infarction and sustained ventricular tachycardia or fibrillation.
Appropriate ICD shock
Time to first appropriate ICD shock - any time post procedure
VT storm
Time to 3 or more episodes of VT within 24 hours - any time post procedure
Treated sustained VT below the detection rate of the ICD
Time to any sustained VT below the detection rate of the ICD; e.g. by external cardioversion, pharmacologic conversion, or manual ICD therapy - any time post procedure
Incessant VT
Time to incessant VT defined as a sustained ventricular arrhythmia which does not terminate despite appropriate external cardioversion/defibrillation or ICD antitachycardia pacing or shocks, or terminates but reinitiates within ≤5 seconds - any time post procedure
Secondary Outcome Measures
Appropriate anti-tachycardia pacing (ATP) from ICD
Appropriate anti-tachycardia pacing (ATP) from ICD - any time post procedure
Inducible for ventricular arrhythmia
Number of inducible for ventricular arrhythmia following catheter ablation guided by PEFA protocol
Number of ventricular arrhythmia events
This is a composite of appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion, and incessant VT - any time during or after the procedure
Escalation and De-escalation of antiarrhythmic medication
Any increase or decrease in the dosage of antiarrhythmic medication either due to inefficacy or side effects will be assessed - any time post procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03870854
Brief Title
Paced Electrogram Feature Analysis (PEFA) for Ablation Targeting in Ischaemic Ventricular Tachycardia
Acronym
PEFA-VT
Official Title
Paced Electrogram Feature Analysis (PEFA) for Ablation Targeting in Ischaemic Ventricular Tachycardia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2019 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Damian Redfearn
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Canadian multicentre prospective cohort study of 40 patients with ischaemic heart disease and therapy from an implantable cardioverter defibrillator (ICD).
Detailed Description
Paced Electrogram Feature Analysis is employed to elucidate VT isthmus sites and target Type I sites for ablation to prevent recurrent VT/VF.
The trial hypothesis is: catheter ablation employing PEFA will, in comparison to published data, reduce the composite outcome of death at any time, appropriate ICD shock, ventricular tachycardia storm or treated sustained ventricular tachycardia below the detection rate of the ICD or incessant VT for patients with prior myocardial infarction and sustained ventricular tachycardia or fibrillation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Ventricular Tachycardia (VT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a Canadian multi-centre prospective cohort study of 40 participants.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEFA targeted substrate ablation
Arm Type
Experimental
Arm Description
Use of PEFA strategy to identify and target VT isthmuses.
Intervention Type
Procedure
Intervention Name(s)
PEFA VT ablation technique
Other Intervention Name(s)
Paced electrogram feature analysis or 'PEFA'
Intervention Description
Catheter ablation guided by PEFA technique
Primary Outcome Measure Information:
Title
All-cause mortality
Description
a composite of death - any time post procedure myocardial infarction and sustained ventricular tachycardia or fibrillation.
Time Frame
3 years
Title
Appropriate ICD shock
Description
Time to first appropriate ICD shock - any time post procedure
Time Frame
3 years
Title
VT storm
Description
Time to 3 or more episodes of VT within 24 hours - any time post procedure
Time Frame
3 years
Title
Treated sustained VT below the detection rate of the ICD
Description
Time to any sustained VT below the detection rate of the ICD; e.g. by external cardioversion, pharmacologic conversion, or manual ICD therapy - any time post procedure
Time Frame
3 years
Title
Incessant VT
Description
Time to incessant VT defined as a sustained ventricular arrhythmia which does not terminate despite appropriate external cardioversion/defibrillation or ICD antitachycardia pacing or shocks, or terminates but reinitiates within ≤5 seconds - any time post procedure
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Appropriate anti-tachycardia pacing (ATP) from ICD
Description
Appropriate anti-tachycardia pacing (ATP) from ICD - any time post procedure
Time Frame
3 years
Title
Inducible for ventricular arrhythmia
Description
Number of inducible for ventricular arrhythmia following catheter ablation guided by PEFA protocol
Time Frame
3 years
Title
Number of ventricular arrhythmia events
Description
This is a composite of appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion, and incessant VT - any time during or after the procedure
Time Frame
3 years
Title
Escalation and De-escalation of antiarrhythmic medication
Description
Any increase or decrease in the dosage of antiarrhythmic medication either due to inefficacy or side effects will be assessed - any time post procedure
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
greater than 18 years of age
Ischaemic heart disease and prior myocardial infarction (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause with documentation of prior ischaemic injury)
Eligible for catheter ablation as standard of care
Implantable Cardioverter Defibrillator
Exclusion Criteria:
Unable or unwilling to provide consent
Both mechanical aortic and mitral valve
LV thrombus,
NYHA class IV heart failure symptoms
Contraindication to heparin
Survival limited to <1 year in estimation of attending care team,
Prior VT ablation Exclusion to standard of care VT catheter ablation procedure such as
Active ischaemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug- induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia.
Non-ischaemic cardiomyopathy because of reduced ablation success and PEFA has not been examined in the context of a non-ischaemic cardiomyopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry Uchitel
Phone
613-533-2148
Email
dmitry.uchitel@kingstonhsc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damian Redfearn, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston Health Sciences Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitry Uchitel
Phone
613-533-2148
Email
Dmitry.Uchitel@kingstonhsc.ca
Email
KGHRI.CARU@kingstonhsc.ca
First Name & Middle Initial & Last Name & Degree
Damian Redfearn
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Porretta, HBSc
Phone
519-685-8500
Ext
32268
Email
Alexander.Porretta@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Lorne Gula
Facility Name
University of Ottawa Heart Institutation
City
Ottawa
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madhuri Thommandru
Phone
613-696-7000
Ext
19080
Email
mthommandru@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Pablo Nery
12. IPD Sharing Statement
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Paced Electrogram Feature Analysis (PEFA) for Ablation Targeting in Ischaemic Ventricular Tachycardia
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