What side effects are associated with this type of intervention?

The most common treatments for Ventricular Tachycardia (VT) include the use of Implantable Cardioverter Defibrillators (ICDs) and antiarrhythmic drugs. ICDs can cause side effects such as infection at the implant site, lead displacement, and inappropriate shocks. Antiarrhythmic drugs, which are often used alongside ICDs, can lead to proarrhythmia, gastrointestinal disturbances, and potential organ toxicity.

What prior FDA approvals exist?

The FDA has approved several treatments for Ventricular Tachycardia, including Implantable Cardioverter Defibrillators (ICDs), which monitor heart rhythms and deliver electrical shocks to correct life-threatening arrhythmias. Additionally, antiarrhythmic drugs such as amiodarone, sotalol, and procainamide have been approved for managing VT. These treatments aim to stabilize heart rhythms and prevent sudden cardiac death in patients with VT.

What other types of research exist?

Promising novel alternatives to ICDs for Ventricular Tachycardia patients in 2024 include: 1) Cardiac Resynchronization Therapy (CRT) with biventricular pacing, which can improve heart function and reduce arrhythmias in selected patients. 2) Conduction system pacing, such as His bundle or left bundle branch pacing, which is an emerging approach that may offer benefits similar to CRT with potentially fewer complications. 3) Advanced pharmacologic therapies, including newer antiarrhythmic drugs that may offer better control of VT with fewer side effects. These alternatives are still under investigation but show potential for improving patient outcomes.

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Procedure

PEFA Ablation Technique for Ventricular Tachycardia (PEFA-VT Trial)

N/A

Recruiting

Led By Damian Redfearn

Research Sponsored by Dr. Damian Redfearn

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Greater than 18 years of age

Eligible for catheter ablation as standard of care

Must not have

LV thrombus

Contraindication to heparin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical risks associated with catheter ablation may include bleeding or infection at the site of insertion, damage to blood vessels or heart tissue, adverse reactions to anesthesia or medications used during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I am a candidate for a procedure to correct heart rhythm problems.

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I have had a heart attack or have heart disease confirmed by tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blood clot in my heart.

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I cannot take heparin due to health reasons.

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I have severe heart failure symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

All-cause mortality

Appropriate ICD shock

Incessant VT

+2 more

Secondary study objectives

Appropriate anti-tachycardia pacing (ATP) from ICD

Escalation and De-escalation of antiarrhythmic medication

Inducible for ventricular arrhythmia

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: PEFA targeted substrate ablationExperimental Treatment1 Intervention

Use of PEFA strategy to identify and target VT isthmuses.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Implantable Cardioverter Defibrillator (ICD) is a critical treatment for Ventricular Tachycardia (VT) as it continuously monitors heart rhythms and delivers electrical shocks to correct life-threatening arrhythmias. The ICD detects abnormal heartbeats and promptly administers a shock to restore normal rhythm, thereby preventing sudden cardiac death. This mechanism is particularly important for VT patients because it provides immediate intervention during arrhythmic episodes, significantly reducing the risk of fatal outcomes.