What is the mechanism of action of this treatment?

Catheter ablation is a common treatment for Atrial Fibrillation (AF) that works by disrupting abnormal electrical pathways in the heart. Techniques such as Pulmonary Vein Antral Isolation (PVAI) isolate the pulmonary veins to prevent erratic electrical signals from triggering AF. Other strategies may target specific drivers of AF or isolate the posterior wall of the left atrium. These treatments are important for AF patients as they help restore and maintain normal heart rhythm, reduce symptoms, and potentially lower the risk of stroke and other AF-related complications.

What side effects are associated with this type of intervention?

Catheter ablation for atrial fibrillation, which includes techniques like PV antral isolation, can lead to complications such as bleeding, infection, and damage to the heart or surrounding structures. There is also a risk of stroke and other cardiovascular events. Antiarrhythmic drugs, often used in conjunction with or as an alternative to ablation, can cause side effects such as bradycardia, QT interval prolongation, and organ toxicity (e.g., liver or lung damage with amiodarone). Both treatment strategies require careful monitoring to manage these risks effectively.

What prior FDA approvals exist?

The FDA has approved several antiarrhythmic drugs for the treatment of Atrial Fibrillation, including amiodarone, sotalol, dofetilide, and dronedarone. These drugs are used to maintain sinus rhythm and manage symptoms in patients with AF. Additionally, catheter ablation, a procedure that disrupts abnormal electrical pathways in the heart, is a widely accepted treatment for AF. This procedure often involves pulmonary vein isolation (PVI) and may include additional techniques such as ablation of drivers or isolation of the posterior wall. The FDA has approved various catheter ablation technologies, including those with open irrigated tip cooling and contact force sensing, to enhance the efficacy and safety of these procedures.

What other types of research exist?

Promising novel alternatives to catheter ablation for atrial fibrillation patients include: 1) Hybrid ablation, which combines surgical and catheter-based techniques to improve outcomes, especially in persistent AF cases. 2) The use of advanced imaging and mapping technologies to precisely target ablation sites, reducing procedure time and improving success rates. 3) Non-thermal ablation methods, such as pulsed field ablation (PFA), which uses electrical fields to selectively ablate cardiac tissue with minimal damage to surrounding structures. 4) Pharmacologic advancements, including new antiarrhythmic drugs that offer better efficacy and safety profiles. 5) Gene therapy and molecular approaches targeting the underlying genetic and molecular mechanisms of AF, which are still in experimental stages but hold potential for future treatments.

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Procedure

Catheter Ablation for Atrial Fibrillation (STARAF3 Trial)

N/A

Recruiting

Led By Atul Verma, Dr.

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

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

Must have

Patients whose AF has been refractory to at least one antiarrhythmic drug

Patients undergoing first-time ablation procedure for AF

Must not have

Patients with paroxysmal AF (no episodes lasting > 7 days)

Patients with very long lasting persistent AF (episodes lasting > 3 years)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-12-18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares three methods of using a catheter to treat patients with persistent atrial fibrillation (AF). The methods involve creating small scars in different parts of the heart to stop abnormal heart rhythms. The goal is to find out which method works best for these patients. Catheter ablation is increasingly being used to treat patients with atrial fibrillation, with recent studies reporting success rates over 70% for persistent AF.

Who is the study for?

This trial is for adults over 18 with persistent atrial fibrillation (AF) lasting more than 3 months but less than three years, who have symptoms like palpitations or shortness of breath. They must have tried at least one antiarrhythmic drug without success and be willing to consent to the study. People can't join if they're pregnant, have paroxysmal AF, a low stroke risk score (CHA2DS2-VASc score of 0), an episode shorter than 3 months or longer than 3 years, or a very large left atrium.

What is being tested?

The study compares three ablation techniques for treating persistent AF: isolating the pulmonary vein area alone (PVAI), PVAI plus targeting 'drivers' that may cause AF, and PVAI plus isolation of the heart's posterior wall. All methods use advanced catheter technology with cooling tips and sensors.

What are the potential side effects?

Ablation procedures might lead to complications such as bleeding or bruising at the catheter insertion site, damage to blood vessels or heart tissue, arrhythmias during recovery, pericarditis (inflammation around the heart), and rarely more serious risks like stroke.

Eligibility Criteria

Inclusion Criteria

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

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My atrial fibrillation didn't improve with at least one medication.

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I am having my first ablation procedure for atrial fibrillation.

Exclusion Criteria

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

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My AFib episodes don't last more than 7 days.

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I have had atrial fibrillation episodes lasting more than 3 years.

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Doctors will not try to correct my irregular heartbeat.

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I cannot take blood thinners or heparin due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-12-18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-12-18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-12-18 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Quality of life measurements during follow-up using AFEQT questionnaire

Quality of life measurements during follow-up using SF12 questionnaires

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: PV antral isolation plus ablation of driversActive Control1 Intervention

PV antral isolation plus ablation of drivers (PVAI+drivers)

Group II: PV antral isolation plus isolation of posterior wallActive Control1 Intervention

PV antral isolation plus isolation of LA posterior wall (PVAI+Box)

Group III: PV antral isolation alone (PVAI)Active Control1 Intervention

PV antral isolation alone (PVAI)

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

Catheter ablation is a common treatment for Atrial Fibrillation (AF) that works by disrupting abnormal electrical pathways in the heart. Techniques such as Pulmonary Vein Antral Isolation (PVAI) isolate the pulmonary veins to prevent erratic electrical signals from triggering AF. Other strategies may target specific drivers of AF or isolate the posterior wall of the left atrium. These treatments are important for AF patients as they help restore and maintain normal heart rhythm, reduce symptoms, and potentially lower the risk of stroke and other AF-related complications.