Ischemic Ventricular Tachycardia (VT)PEFA-VTNCT03870854
Paced Electrogram Feature Analysis (PEFA) for Ablation Targeting in Ischaemic Ventricular Tachycardia
A study testing PEFA VT ablation technique in people with Ischemic Ventricular Tachycardia (VT), run by Dr. Damian Redfearn at 3 sites in Canada.
Trial summary
Canadian multicentre prospective cohort study of 40 patients with ischaemic heart disease and therapy from an implantable cardioverter defibrillator (ICD). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ischemic Ventricular Tachycardia (VT)
- What is being tested?
- PEFA VT ablation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesCanada
- Study dates
- 13 Aug 2019to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Dmitry Uchitel, 613-533-2148, Dmitry.Uchitel@kingstonhsc.ca
KGHRI.CARU@kingstonhsc.ca
- Not yet recruiting
London Health Sciences Centre
London, Ontario, N6A 5A5
Alexander Porretta, HBSc, 519-685-8500 ext. 32268, Alexander.Porretta@lhsc.on.ca
Lorne Gula
- Not yet recruiting
University of Ottawa Heart Institutation
Ottawa, Ontario
Madhuri Thommandru, 613-696-7000 ext. 19080, mthommandru@ottawaheart.ca
Pablo Nery
About this study
Canadian multicentre prospective cohort study of 40 patients with ischaemic heart disease and therapy from an implantable cardioverter defibrillator (ICD).
Read the 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.
- Conditions
- Ischemic Ventricular Tachycardia (VT)
- Being tested
- PEFA VT ablation technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEFA VT ablation techniqueProcedure or surgery
Also called Paced electrogram feature analysis or 'PEFA'
Catheter ablation guided by PEFA technique
| Study group | Role | What they receive |
|---|---|---|
| PEFA targeted substrate ablation | Experimental | Use of PEFA strategy to identify and target VT isthmuses. Receives: Procedure: PEFA VT ablation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
a composite of death - any time post procedure myocardial infarction and sustained ventricular tachycardia or fibrillation.
Measured: 3 years
Appropriate ICD shock
Time to first appropriate ICD shock - any time post procedure
Measured: 3 years
VT storm
Time to 3 or more episodes of VT within 24 hours - any time post procedure
Measured: 3 years
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
Measured: 3 years
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
Measured: 3 years
Secondary outcomes (4)
Appropriate anti-tachycardia pacing (ATP) from ICD
Appropriate anti-tachycardia pacing (ATP) from ICD - any time post procedure
Measured: 3 years
Inducible for ventricular arrhythmia
Number of inducible for ventricular arrhythmia following catheter ablation guided by PEFA protocol
Measured: 3 years
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
Measured: 3 years
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start13 Aug 2019
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Ventricular Tachycardia (VT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a Canadian multi-centre prospective cohort study of 40 participants.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Damian Redfearn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Damian Redfearn, Queen's University
- Investigators
- Damian Redfearn, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870854
- Sponsor's protocol ID
- CTO-PA #1723
- Acronym
- PEFA-VT
- Status last verified
- Nov 2023
- First submitted
- 6 Mar 2019
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paced Electrogram Feature Analysis (PEFA) for Ablation Targeting in Ischaemic Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT03870854
- Acronym / sponsor ID
- PEFA-VT / CTO-PA #1723
- Conditions
- Ischemic Ventricular Tachycardia (VT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dr. Damian RedfearnUniversity, hospital or other
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a Canadian multi-centre prospective cohort study of 40 participants.
| Arm | Type | Receives |
|---|---|---|
| PEFA targeted substrate ablation | Experimental | Procedure: PEFA VT ablation techniqueUse of PEFA strategy to identify and target VT isthmuses. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Unable or unwilling to provide consent
- Both mechanical aortic and mitral valve
- LV thrombus,
- NYHA class IV heart failure symptoms
- Contraindication to heparin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEFA VT ablation techniqueAlso: Paced electrogram feature analysis or 'PEFA'Catheter ablation guided by PEFA technique | Procedure or surgery | PEFA targeted substrate ablation |
Primary outcome
All-cause mortality
Time frame: 3 years
a composite of death - any time post procedure myocardial infarction and sustained ventricular tachycardia or fibrillation.
Appropriate ICD shock
Time frame: 3 years
Time to first appropriate ICD shock - any time post procedure
VT storm
Time frame: 3 years
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 frame: 3 years
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 frame: 3 years
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
4 secondary outcomes
Appropriate anti-tachycardia pacing (ATP) from ICD
Time frame: 3 years
Inducible for ventricular arrhythmia
Time frame: 3 years
Number of ventricular arrhythmia events
Time frame: 3 years
Escalation and De-escalation of antiarrhythmic medication
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damian Redfearn, MD principal investigator
Queen's University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEFA VT ablation technique in people with Ischemic Ventricular Tachycardia (VT), run by Dr. Damian Redfearn at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmitry Uchitel (613-533-2148, dmitry.uchitel@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.