PEFA Ablation Technique for Ventricular Tachycardia
(PEFA-VT Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dr. Damian Redfearn
Disqualifiers: Mechanical valves, LV thrombus, NYHA IV, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
678910How 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.
36111213Eligibility 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.
+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.
+5 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
London Health Sciences CentreLondon, Canada
University of Ottawa Heart InstitutationOttawa, Canada
Kingston Health Sciences CentreKingston, Canada
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Who Is Running the Clinical Trial?
Dr. Damian RedfearnLead Sponsor
Dr. Damian RedfearnLead Sponsor
References
Mapping for ventricular tachycardia. [2019]Mapping strategies for ventricular tachycardia (VT) have evolved significantly in the past 2 decades. This review discusses mapping techniques that can help in successful VT ablation. The electrocardiogram (ECG) remains a vital component of VT mapping and can help to identify the chamber of origin of VT. The ECG morphology of VT, however, is influenced by orientation of heart and location of the scar. Activation mapping during VT is an important technique that can help in further localization. Care has to be exercised to ensure that small signals are not ignored and far-field signals are recognized. Pace-mapping to mimic the VT is another way to map exit site for scar based reentrant VT or the site of origin of triggered and automatic VT in the absence of structural heart disease. For the latter group, this technique is widely used in determining the site of ablation. It is important to ensure a complete ECG match (12 out of 12 leads) of the pace-map to the clinical arrhythmia in these patients. In patients with structural heart disease, entrainment mapping remains the gold standard for defining the protected isthmus and other components of the VT circuit. Using this technique, successful ablation of reentrant VT can be achieved in 60-90% of patients. In order to perform entrainment mapping, the VT has to be hemodynamically tolerated; this is not the case in 25% of pts with scar based reentrant VT. The development of 3-dimensional mapping systems allows for more anatomically based linear ablation in patients with poorly tolerated uniform VT. Despite these advances, there are still about 10-20% VTs that cannot be ablated successfully with the above described techniques, especially in patients with structural heart disease. Other recent advances such as percutaneous closed chest epicardial mapping technique and cooled tip ablation catheter technology have the potential to enhance mapping and successful ablation of VT.
Use of Novel Electrogram "Lumipoint" Algorithm to Detect Critical Isthmus and Abnormal Potentials for Ablation in Ventricular Tachycardia. [2020]This study reports the use of a novel "Lumipoint" algorithm in ventricular tachycardia (VT) ablation.
An automated fractionation mapping algorithm for mapping of scar-based ventricular tachycardia. [2020]Mapping and ablation of fractionated electrograms is a common treatment for scar-based ventricular tachycardia (VT). An automated algorithm has been developed for rapid "fractionation mapping."
[Catheter ablation of ventricular tachycardia]. [2016]Since the last decade important advances in diagnostics, understanding and the ablation techniques of ventricular tachycardia (VT) have been made. Both, patients with idiopathic VT and patients with structural heart disease and scar-related VT undergo VT ablation, that targets the underlying substrate responsible for VT development. Use of 3-dimensional electro-anatomic mapping systems enables identification of scar-related slow conduction sites, that are the critical players in scar-related VT. Successful mapping and ablation of mono- and polymorphic VT and ventricular fibrillation is achieved at specialized centers and is associated with reduced hospitalizations and mortality in patients with recurrent ICD shocks. This article describes the mechanisms of VTs, current mapping and ablation techniques and the results and complications of VT ablation at experienced VT ablation centers.
Strategies for catheter ablation of scar-related ventricular tachycardia. [2019]Ventricular tachycardia (VT) due to reentry in and around regions of ventricular scar from an old myocardial infarction or cardiomyopathic process is often a difficult management problem. Radiofrequency catheter ablation is an option for controlling frequent VT episodes. Patient and VT characteristics determine the mapping and ablation approach and efficacy. In patients with a VT that is hemodynamically tolerated to allow mapping, prevention of recurrent VT is achieved in 54% to 66% of patients with a procedure related mortality of 1% to 2.7%. Multiple morphologies of monomorphic VT and circuits that are located deep to the endocardium are common problems that reduce efficacy. Mapping to identify target regions for ablation can be difficult if VT is rapid and not tolerated, or not inducible. Ablation of these "unmappable VTs" by designing ablation lines or areas based on the characteristics of the scar as assessed during sinus rhythm, and using approaches to assess global activation from a limited number of beats has been shown to be feasible. Ablation of multiple VTs, epicardial VTs, and poorly tolerated VTs are feasible. Future studies defining efficacy and risks are needed.
Investigator-reported ventricular arrhythmias and mortality in heart failure with mildly reduced or preserved ejection fraction. [2023]Few reports have examined the incidence of ventricular tachycardia (VT) and ventricular fibrillation (VF) or their relationship with mortality in patients with heart failure with mildly reduced ejection fraction (HFmrEF) or heart failure with preserved ejection fraction (HFpEF).
Bradycardia pacing-induced short-long-short sequences at the onset of ventricular tachyarrhythmias: a possible mechanism of proarrhythmia? [2007]The purpose of this study was to characterize interactions between normal pacing system operation and the initiating sequence of ventricular tachycardia (VT)/ventricular fibrillation (VF).
Epicardial ventricular tachycardia ablation a multicenter safety study. [2022]The aim of this study was to perform a systematic evaluation of safety and midterm complications after epicardial ventricular tachycardia (VT) ablation.
Risk score model for predicting complications in patients undergoing ventricular tachycardia ablation: insights from the National Inpatient Sample database. [2020]Outcome data on ventricular tachycardia (VT) ablation has been limited to few experienced centres. We sought to identify complication rates, predictors, and create a risk score model for predicting complications in patients from real-world data.
Safety of ventricular tachycardia ablation in clinical practice: findings from 9699 hospital discharge records. [2023]Outcomes of ventricular tachycardia (VT) ablation have been described in clinical trials and single-center studies. We assessed the safety of VT ablation in clinical practice.
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]The identification of low-voltage proarrhythmic areas for catheter ablation of scar-mediated ventricular tachycardia (VT) remains challenging. Integration of myocardial perfusion imaging (single-photon emission computed tomography/computed tomography; SPECT/CT) and electroanatomical mapping (EAM) may improve delineation of the arrhythmogenic substrate.
Mapping and ablating ventricular premature contractions that trigger ventricular fibrillation: trigger elimination and substrate modification. [2015]Ventricular fibrillation (VF) is a malignant arrhythmia, usually initiated by a ventricular premature contraction (VPC) during the vulnerable period of cardiac repolarization. Ablation therapy for VF has been described and increasingly reported. Targets for VF triggers are VPC preceded Purkinje potentials or the right ventricular outflow tract (RVOT) in structurally normal hearts, and VPC triggers preceded by Purkinje potentials in ischemic cardiomyopathy. The most important issue before the ablation session is the recording of the 12-lead electrocardiogram (ECG) of the triggering event, which can prove invaluable in regionalizing the origin of the triggering VPC for more detailed mapping. In cases where the VPC is not spontaneous or inducible, ablation may be performed by pacemapping. During the session, mapping should be focused on the earliest activation and determining the earliest potential is the key to a successful ablation. However, a modification of the Purkinje network might be applied when the earliest site cannot be determined or is located close to the His-bundle. Furthermore, the electrical isolation of the pulmonary artery (PA) can suppress RVOT type polymorphic ventricular tachycardia in some patients with rapid triggers from the PA. Suppression of VF can be achieved by not only the elimination of triggering VPCs, but also by substrate modification of possible reentry circuits in the Purkinje network, or between the PA and RVOT. Further studies are needed to evaluate the precise mechanisms of this arrhythmia.
Catheter ablation of polymorphic ventricular tachycardia/fibrillation in patients with and without structural heart disease. [2020]Catheter ablation for polymorphic ventricular tachycardia and ventricular fibrillation (PMVT/VF) may target triggering premature ventricular contractions (PVCs). Targeting ventricular scar has also been suggested, but data are limited.