Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Paced Electrogram Feature Analysis (PEFA) for Ablation Targeting in Ischaemic Ventricular Tachycardia (PEFA-VT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03870854
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Damian Redfearn, Queen's University

Brief Summary:
Canadian multicentre prospective cohort study of 40 patients with ischaemic heart disease and therapy from an implantable cardioverter defibrillator (ICD).

Condition or disease Intervention/treatment Phase
Ischemic Ventricular Tachycardia (VT) Procedure: PEFA VT ablation technique Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a Canadian multi-centre prospective cohort study of 40 participants.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Paced Electrogram Feature Analysis (PEFA) for Ablation Targeting in Ischaemic Ventricular Tachycardia
Actual Study Start Date : August 13, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEFA targeted substrate ablation
Use of PEFA strategy to identify and target VT isthmuses.
Procedure: PEFA VT ablation technique
Catheter ablation guided by PEFA technique
Other Name: Paced electrogram feature analysis or 'PEFA'




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 3 years ]
    a composite of death - any time post procedure myocardial infarction and sustained ventricular tachycardia or fibrillation.

  2. Appropriate ICD shock [ Time Frame: 3 years ]
    Time to first appropriate ICD shock - any time post procedure

  3. VT storm [ Time Frame: 3 years ]
    Time to 3 or more episodes of VT within 24 hours - any time post procedure

  4. 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

  5. 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


Secondary Outcome Measures :
  1. Appropriate anti-tachycardia pacing (ATP) from ICD [ Time Frame: 3 years ]
    Appropriate anti-tachycardia pacing (ATP) from ICD - any time post procedure

  2. Inducible for ventricular arrhythmia [ Time Frame: 3 years ]
    Number of inducible for ventricular arrhythmia following catheter ablation guided by PEFA protocol

  3. Number of ventricular arrhythmia events [ Time Frame: 3 years ]
    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

  4. Escalation and De-escalation of antiarrhythmic medication [ Time Frame: 3 years ]
    Any increase or decrease in the dosage of antiarrhythmic medication either due to inefficacy or side effects will be assessed - any time post procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03870854


Contacts
Layout table for location contacts
Contact: Sharlene Hammond 613-533-2148 Sharlene.Hammond@kingstonhsc.ca

Locations
Layout table for location information
Canada, Ontario
Kingston Health Sciences Centre Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Sharlene Hammond    613-533-2148    Sharlene.Hammond@kingstonhsc.ca   
Contact       KGHRI.CARU@kingstonhsc.ca   
Principal Investigator: Damian Redfearn         
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5A5
Contact: Alexander Porretta, HBSc    519-685-8500 ext 32268    Alexander.Porretta@lhsc.on.ca   
Principal Investigator: Lorne Gula         
University of Ottawa Heart Institutation Not yet recruiting
Ottawa, Ontario, Canada
Contact: Madhuri Thommandru    613-696-7000 ext 19080    mthommandru@ottawaheart.ca   
Principal Investigator: Pablo Nery         
Sponsors and Collaborators
Dr. Damian Redfearn
Investigators
Layout table for investigator information
Principal Investigator: Damian Redfearn Kingston Health Sciences Centre

Layout table for additonal information
Responsible Party: Dr. Damian Redfearn, MB CHB MD MRCPI FRCPC Professor of Medicine, Kingston Health Sciences Centre, Queen's University
ClinicalTrials.gov Identifier: NCT03870854     History of Changes
Other Study ID Numbers: CTO-PA #1723
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tachycardia
Tachycardia, Ventricular
Ischemia
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease