PEFA Ablation Technique for Ventricular Tachycardia

(PEFA-VT Trial)

Recruiting at 2 trial locations

Overseen By Dmitry Uchitel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Damian Redfearn

Disqualifiers: Mechanical valves, LV thrombus, NYHA IV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

40 Participants Needed

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{7 10 11 12 13}

Research Team

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.

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.

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

Group I: PEFA targeted substrate ablation Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An automated fractionation mapping algorithm for mapping of scar-based ventricular tachycardia. Launer, H., Clark, T., Dewland, T., et al.[2020]

Advancements in 3-dimensional electro-anatomic mapping have improved the identification and ablation of scar-related ventricular tachycardia (VT), leading to successful treatment outcomes at specialized centers.

VT ablation has been associated with reduced hospitalizations and mortality in patients experiencing recurrent ICD shocks, highlighting its efficacy in managing this serious heart condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Catheter ablation of ventricular tachycardia]. Jadidi, AS.[2016]

Radiofrequency catheter ablation can effectively control frequent episodes of ventricular tachycardia (VT) in patients, achieving prevention of recurrent VT in 54% to 66% of cases, with a low procedure-related mortality rate of 1% to 2.7%.

Challenges such as multiple VT morphologies and deep circuits can reduce the efficacy of ablation, but innovative mapping techniques for 'unmappable VTs' based on scar characteristics have shown promise, indicating that further studies are needed to better define the risks and benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for catheter ablation of scar-related ventricular tachycardia. Stevenson, WG., Delacretaz, E.[2019]

In a study of 13,609 patients with heart failure, only 1.1% experienced ventricular tachycardia (VT) or ventricular fibrillation (VF), indicating these events are relatively uncommon but significant.

The occurrence of VT/VF was strongly linked to increased mortality risk, with an adjusted hazard ratio of 3.95, suggesting that while VT/VF may not indicate a risk of sudden death, they are markers of disease severity in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigator-reported ventricular arrhythmias and mortality in heart failure with mildly reduced or preserved ejection fraction. Curtain, JP., Adamson, C., Kondo, T., et al.[2023]

In a study analyzing 1,356 episodes of ventricular tachycardia (VT) and ventricular fibrillation (VF), it was found that abrupt changes in ventricular cycle lengths (short-long-short sequences) can initiate these dangerous heart rhythms, particularly in patients with bradycardia pacing.

The research revealed that pacing can either permit or actively facilitate the onset of VT/VF, with pacing facilitated sequences accounting for a significant portion of episodes, highlighting a potential mechanism for ventricular proarrhythmia in patients with implantable cardioverter-defibrillators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bradycardia pacing-induced short-long-short sequences at the onset of ventricular tachyarrhythmias: a possible mechanism of proarrhythmia? Sweeney, MO., Ruetz, LL., Belk, P., et al.[2007]

In a study of 913 ventricular tachycardia (VT) ablation procedures, 156 (17%) required epicardial mapping and/or ablation, with a 5% rate of major acute complications related to epicardial access, including bleeding and coronary stenosis.

After a mean follow-up of 23 months, there were 2% of delayed complications, such as pericardial inflammatory reactions and coronary occlusions, indicating that while epicardial VT ablation is effective, it carries notable risks that need to be monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epicardial ventricular tachycardia ablation a multicenter safety study. Sacher, F., Roberts-Thomson, K., Maury, P., et al.[2022]

A study of 25,451 patients undergoing ventricular tachycardia (VT) ablation revealed an overall complication rate of 14.7% and an in-hospital mortality rate of 2.8%, highlighting the risks associated with this procedure.

A newly developed risk score model effectively predicts complications based on factors like age, chronic kidney disease, and emergency procedures, with complication rates increasing significantly from 2.7% in low-risk patients to 31% in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk score model for predicting complications in patients undergoing ventricular tachycardia ablation: insights from the National Inpatient Sample database. Gunda, S., Padala, SK., Saini, A., et al.[2020]

In a study of 9699 hospitalizations for ventricular tachycardia (VT) ablation, adverse events (AEs) occurred in 8.5% of cases, with major AEs in 3.0% and a mortality rate of 1.1%, indicating that while VT ablation is generally safe, there are significant risks involved.

The study found that higher hospital procedural volumes (more than 25 cases per year) were associated with lower rates of AEs, suggesting that choosing experienced centers for VT ablation may enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of ventricular tachycardia ablation in clinical practice: findings from 9699 hospital discharge records. Katz, DF., Turakhia, MP., Sauer, WH., et al.[2023]

The integration of SPECT/CT imaging with electroanatomical mapping (EAM) in 20 patients undergoing ventricular tachycardia (VT) ablation showed a 70% concordance in identifying scarred versus viable heart tissue, indicating that this method can effectively enhance the mapping of arrhythmogenic areas.

EAM demonstrated a sensitivity of 68.5% and specificity of 76.4% when compared to SPECT/CT, suggesting that while the integration improves identification of problematic areas, there is still room for improvement in accuracy.

NCBI (Pubmed)

pubmed.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. Thibault, B., Richer, LP., McSpadden, LC., et al.[2022]

Ablation therapy for ventricular fibrillation (VF) can effectively target ventricular premature contractions (VPCs) that trigger VF, particularly those associated with Purkinje potentials or in the right ventricular outflow tract (RVOT) in structurally normal hearts.

Successful ablation relies on accurately mapping the earliest activation sites of VPCs, and in some cases, modifying the Purkinje network or electrically isolating the pulmonary artery can help suppress VF triggers, indicating a multifaceted approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping and ablating ventricular premature contractions that trigger ventricular fibrillation: trigger elimination and substrate modification. Nogami, A.[2015]

In a study of 32 patients with recurrent polymorphic ventricular tachycardia (PMVT) or ventricular fibrillation (VF), those with structural heart disease (SHD) often had low-voltage myocardial scars, which were linked to triggering premature ventricular contractions (PVCs) and sustained monomorphic ventricular tachycardia (SMVT).

Both SHD and idiopathic VF patients showed similar success rates in preventing recurrence after catheter ablation, with 74% of SHD patients and 77% of idiopathic VF patients remaining free of recurrence over a median follow-up of 540 days, indicating that targeting scar tissue can be an effective treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation of polymorphic ventricular tachycardia/fibrillation in patients with and without structural heart disease. Nakamura, T., Schaeffer, B., Tanigawa, S., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mapping for ventricular tachycardia. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Use of Novel Electrogram "Lumipoint" Algorithm to Detect Critical Isthmus and Abnormal Potentials for Ablation in Ventricular Tachycardia. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

An automated fractionation mapping algorithm for mapping of scar-based ventricular tachycardia. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

[Catheter ablation of ventricular tachycardia]. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Strategies for catheter ablation of scar-related ventricular tachycardia. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Investigator-reported ventricular arrhythmias and mortality in heart failure with mildly reduced or preserved ejection fraction. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Bradycardia pacing-induced short-long-short sequences at the onset of ventricular tachyarrhythmias: a possible mechanism of proarrhythmia? [2007]

8. United States pubmed.ncbi.nlm.nih.gov

Epicardial ventricular tachycardia ablation a multicenter safety study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Risk score model for predicting complications in patients undergoing ventricular tachycardia ablation: insights from the National Inpatient Sample database. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Safety of ventricular tachycardia ablation in clinical practice: findings from 9699 hospital discharge records. [2023]

11. United States pubmed.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 States pubmed.ncbi.nlm.nih.gov

Mapping and ablating ventricular premature contractions that trigger ventricular fibrillation: trigger elimination and substrate modification. [2015]

13. United States pubmed.ncbi.nlm.nih.gov

Catheter ablation of polymorphic ventricular tachycardia/fibrillation in patients with and without structural heart disease. [2020]