40 Participants Needed

PEFA Ablation Technique for Ventricular Tachycardia

(PEFA-VT Trial)

Recruiting at 2 trial locations
SH
DU
Overseen ByDmitry Uchitel
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dr. Damian Redfearn
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the PEFA VT ablation technique treatment for ventricular tachycardia?

The research highlights that advanced mapping techniques, like those used in the PEFA VT ablation, can help identify critical areas in the heart for successful treatment of ventricular tachycardia. These techniques have been associated with reduced hospitalizations and mortality in patients with recurrent heart rhythm issues.12345

Is the PEFA Ablation Technique for Ventricular Tachycardia safe for humans?

Studies on ventricular tachycardia (VT) ablation, which may include techniques like PEFA, have shown that it is generally safe in clinical practice, with safety evaluated in large groups of patients. However, as with any medical procedure, there are risks of complications, and these can vary based on individual health conditions.678910

How is the PEFA VT ablation technique different from other treatments for ventricular tachycardia?

The PEFA VT ablation technique is unique because it uses Paced Electrogram Feature Analysis to precisely identify and target the areas of the heart responsible for ventricular tachycardia, potentially offering a more accurate and effective treatment compared to traditional methods that rely on broader mapping and ablation strategies.36111213

What is the purpose of this trial?

This trial tests a new procedure that uses a special technique to find and fix areas in the heart causing dangerous rhythms in patients with heart disease and previous heart attacks. The goal is to reduce life-threatening heart rhythm problems better than current treatments.

Research Team

DR

Damian Redfearn, MD

Principal Investigator

Queen's University

Eligibility Criteria

This trial is for adults over 18 with ischemic heart disease and a history of myocardial infarction, who have an ICD implanted and are eligible for catheter ablation. It's not suitable for those unable to consent, with severe heart failure symptoms or mechanical heart valves, blood clot in the heart, contraindication to heparin, life expectancy under one year, recent acute coronary syndrome or prior VT ablation.

Inclusion Criteria

I am older than 18 years.
You have an implanted device that can help manage irregular heartbeats.
I have had a heart attack or have heart disease confirmed by tests.
See 1 more

Exclusion Criteria

I have a blood clot in my heart.
I have not been excluded from standard VT ablation due to recent heart issues or specific heart conditions.
I cannot take heparin due to health reasons.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo catheter ablation using the PEFA strategy to target VT isthmuses

1-2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of ventricular arrhythmia events and antiarrhythmic medication adjustments

3 years

Treatment Details

Interventions

  • PEFA VT ablation technique
Trial Overview The study tests the PEFA VT ablation technique on patients with ischemic ventricular tachycardia. This Canadian multicentre prospective cohort study involves 40 participants who have received therapy from an implantable cardioverter defibrillator due to their condition.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: PEFA targeted substrate ablationExperimental Treatment1 Intervention
Use of PEFA strategy to identify and target VT isthmuses.

PEFA VT ablation technique is already approved in Canada for the following indications:

🇨🇦
Approved in Canada as PEFA VT ablation technique for:
  • Ischaemic ventricular tachycardia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dr. Damian Redfearn

Lead Sponsor

Trials
1
Recruited
40+

Dr. Damian Redfearn

Lead Sponsor

Trials
1
Recruited
40+

Findings from Research

Electrocardiogram (ECG) mapping techniques, including activation mapping and pace-mapping, are crucial for accurately localizing the origin of ventricular tachycardia (VT) and determining effective ablation sites, with success rates of 60-90% for reentrant VT in patients with structural heart disease.
Despite advancements in mapping technologies, including 3-dimensional systems and new ablation techniques, 10-20% of VTs remain difficult to ablate, particularly in patients with structural heart issues, highlighting the need for ongoing innovation in this area.
Mapping for ventricular tachycardia.Dixit, S., Callans, DJ.[2019]
The Lumipoint algorithm improves the mapping of ventricular tachycardia (VT) by analyzing complete electrogram tracings, which helps identify critical areas like late potentials and VT isthmus that standard methods might miss.
In a study involving 27 patients with ischemic and dilated cardiomyopathy, the algorithm successfully identified VT isthmus in 25 cases, enhancing the accuracy of ablation strategies, especially in low voltage areas.
Use of Novel Electrogram "Lumipoint" Algorithm to Detect Critical Isthmus and Abnormal Potentials for Ablation in Ventricular Tachycardia.Martin, CA., Takigawa, M., Martin, R., et al.[2020]
An automated fractionation mapping algorithm was tested on 21 ablation procedures, successfully identifying over 50% of scar-based ventricular tachycardia (VT) ablation sites with optimal parameter settings, which could enhance the effectiveness of the procedure.
The study found that using specific mapping parameters significantly reduced the area of fractionation in control patients, indicating high specificity, and only 23% of scar-based VT patients experienced recurrence after an average follow-up of 15 months, suggesting improved long-term outcomes.
An automated fractionation mapping algorithm for mapping of scar-based ventricular tachycardia.Launer, H., Clark, T., Dewland, T., et al.[2020]

References

Mapping for ventricular tachycardia. [2019]
Use of Novel Electrogram "Lumipoint" Algorithm to Detect Critical Isthmus and Abnormal Potentials for Ablation in Ventricular Tachycardia. [2020]
An automated fractionation mapping algorithm for mapping of scar-based ventricular tachycardia. [2020]
[Catheter ablation of ventricular tachycardia]. [2016]
Strategies for catheter ablation of scar-related ventricular tachycardia. [2019]
Investigator-reported ventricular arrhythmias and mortality in heart failure with mildly reduced or preserved ejection fraction. [2023]
Bradycardia pacing-induced short-long-short sequences at the onset of ventricular tachyarrhythmias: a possible mechanism of proarrhythmia? [2007]
Epicardial ventricular tachycardia ablation a multicenter safety study. [2022]
Risk score model for predicting complications in patients undergoing ventricular tachycardia ablation: insights from the National Inpatient Sample database. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Safety of ventricular tachycardia ablation in clinical practice: findings from 9699 hospital discharge records. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Integration of 3D nuclear imaging in 3D mapping system for ventricular tachycardia ablation in patients with implanted devices: Perfusion/voltage retrospective assessment of scar location. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Mapping and ablating ventricular premature contractions that trigger ventricular fibrillation: trigger elimination and substrate modification. [2015]
13.United Statespubmed.ncbi.nlm.nih.gov
Catheter ablation of polymorphic ventricular tachycardia/fibrillation in patients with and without structural heart disease. [2020]
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