What side effects are associated with this type of intervention?

The most common treatments for Atrial Fibrillation (AF) include catheter ablation and antiarrhythmic drugs. Catheter ablation can lead to complications such as bleeding, infection, cardiac tamponade, and pulmonary vein stenosis. Antiarrhythmic drugs like amiodarone and dronedarone have side effects including thyroid dysfunction, liver toxicity, and pulmonary fibrosis for amiodarone, and increased cardiovascular events for dronedarone, especially in patients with permanent AF.

What prior FDA approvals exist?

The FDA has approved several treatments for Atrial Fibrillation, including antiarrhythmic drugs and catheter ablation techniques. Antiarrhythmic drugs such as amiodarone, dofetilide, and dronedarone have been approved to maintain sinus rhythm in AF patients. Catheter ablation, particularly Pulmonary Vein Isolation (PVI), is a widely accepted procedure for treating paroxysmal AF. The Volta's VX1 algorithm, which is being studied to enhance the effectiveness of repeat catheter ablation, represents an advancement in this area, aiming to improve outcomes for patients with recurrent AF after initial ablation procedures.

What other types of research exist?

Promising novel alternatives to Volta's VX1 algorithm for AF treatment include the second-generation PVAC Gold ablation catheter, which improves the safe delivery of phased radiofrequency energy for pulmonary vein isolation, and the use of Ablation Index (AI) guided point-by-point PVI, which has shown improved outcomes in maintaining sinus rhythm. Additionally, the NavX 3D electroanatomical mapping system has been effective in guiding catheter ablation procedures.

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Procedure

Tailored Catheter Ablation for Atrial Fibrillation (RESTART Trial)

N/A

Waitlist Available

Research Sponsored by Volta Medical

Eligibility Criteria Checklist

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

Must have

Documented symptomatic AF recurrences that occurred within the last 12 months and persisted beyond 3 months after the last AF ablation procedure

Patients 21 years of age or older indicated for redo AF ablation

Must not have

Long-standing persistent AF recurrence prior to study redo procedure

Severe obesity (BMI > 50)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a computer program combined with a medical procedure to help patients whose irregular heartbeat has returned. The program helps doctors find and fix the problem areas in the heart more effectively.

Who is the study for?

This trial is for adults over 21 with recurrent Atrial Fibrillation (AF) after previous catheter or surgical ablation. Participants must have had symptomatic AF in the last year and been on anticoagulants like warfarin or NOACs for at least 4 weeks. Exclusions include severe heart failure, recent clots, major lung disease, very dilated Left Atrium, pregnancy, and certain other health conditions.

What is being tested?

The study tests a tailored repeat catheter ablation approach using Volta's VX1 algorithm in patients whose AF returned after initial treatment. It's an international multi-center trial that isn't randomized; all participants receive the intervention to see how well it works.

What are the potential side effects?

While specific side effects are not listed here, typical risks of catheter ablation may include bleeding at the site where the catheter was inserted, damage to blood vessels or heart valves from the catheter, arrhythmias (irregular heartbeats), infection risk from invasive procedures.

Eligibility Criteria

Inclusion Criteria

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

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I have had symptoms of AF that lasted even 3 months after my last AF treatment.

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I am 21 or older and need a repeat procedure for atrial fibrillation.

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I have had a procedure to treat irregular heartbeats.

Exclusion Criteria

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

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My atrial fibrillation has come back before the study's redo procedure.

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My BMI is over 50, indicating severe obesity.

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I have been diagnosed with atrial myxoma.

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My heart's left atrium is very enlarged.

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I have a history of abnormal blood clotting or bleeding.

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I have not had any heart surgery, including stent placement, in the last 2 months.

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I have a blood clot in my heart as seen on a special heart scan.

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I do not have any current infections or severe illnesses.

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I currently have an acute Covid-19 infection with fever or inflammation.

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I have severe lung disease or chronic respiratory symptoms.

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My first AF ablation was for persistent AF lasting over 24 months.

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I have had AF ablation with VX1 software before.

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I have had complications from a previous ablation procedure.

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My heart function is severely impaired.

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My atrial fibrillation is due to a treatable cause.

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I have had severe chest pain within the last month.

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I have had surgery on my heart's atrioventricular valve.

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I cannot take blood thinners like heparin, warfarin, or NOACs.

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I have had a stroke or similar event in the last year.

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I have been diagnosed with thickened heart muscles.

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I have been diagnosed with cardiac sarcoidosis.

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I have been diagnosed with rheumatic heart disease.

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I cannot have a catheter due to a blockage or condition in my blood vessels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Freedom from AF

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

Patients undergoing catheter ablation that qualify after initial screening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Catheter Ablation

2016

Completed Phase 4

~3920

0 / 26Eligibility 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

Common treatments for Atrial Fibrillation (AF) include rate control, rhythm control, and catheter ablation. Rate control uses medications to slow the heart rate, while rhythm control aims to restore normal heart rhythm through drugs or electrical cardioversion. Catheter ablation, particularly advanced techniques like those enhanced by Volta's VX1 algorithm, targets and disrupts abnormal electrical pathways in the heart. These treatments are crucial for AF patients as they help manage symptoms, reduce the risk of complications such as stroke, and improve overall quality of life.

Atrial fibrillation: basic and clinical research at the Montreal Heart Institute.