What side effects are associated with this type of intervention?

Common treatments for Atrial Fibrillation (AF) include electrical cardioversion, pharmacologic cardioversion, and catheter ablation. Electrical cardioversion, which uses direct current to reset the heart's rhythm, can cause skin burns, arrhythmias, and in rare cases, thromboembolism. Pharmacologic cardioversion, involving drugs like amiodarone or sotalol, may lead to side effects such as hypotension, bradycardia, and proarrhythmia. Catheter ablation, which creates lesions in heart tissue to disrupt faulty electrical pathways, can result in complications like bleeding, infection, and damage to the heart or surrounding structures. Pulsed field ablation, a newer technique, aims to minimize these risks by using short, high-voltage electrical pulses to create precise lesions, but its long-term safety profile is still under investigation.

What prior FDA approvals exist?

The FDA has approved several treatments for Atrial Fibrillation, including antiarrhythmic drugs like ibutilide and procainamide, which are used for pharmacologic cardioversion. Additionally, catheter ablation techniques, such as radiofrequency ablation (RFA) and cryoablation, have been approved for AF treatment. These methods involve creating lesions in heart tissue to disrupt abnormal electrical pathways. The Globe® Pulsed Field System, which uses pulsed field ablation (PFA), represents a newer approach that aims to achieve similar outcomes with potentially fewer complications and greater procedural efficiency.

What other types of research exist?

Promising novel alternatives to the Globe® Pulsed Field System for treating atrial fibrillation in 2024 include cryoballoon ablation, which uses extreme cold to create lesions in heart tissue, and hybrid or convergent ablation strategies that combine various energy sources for more effective treatment, especially in persistent AF cases. These methods have shown encouraging medium and long-term results.

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Procedure

Globe Pulsed Field Ablation for Atrial Fibrillation (PULSAR Trial)

N/A

Recruiting

Research Sponsored by Kardium Inc.

Eligibility Criteria Checklist

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

Must have

Diagnosis of recurrent symptomatic paroxysmal or persistent AF

Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III

Must not have

Atrial fibrillation secondary to a reversible cause or of non-cardiac origin

Prior left atrial ablation or surgical procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device that uses electrical pulses to treat people with irregular heartbeats. It focuses on patients who have noticeable symptoms of occasional or ongoing atrial fibrillation. The goal is to see if the device is safe and effective.

Who is the study for?

This trial is for people with a type of heart rhythm disorder called symptomatic paroxysmal or persistent atrial fibrillation, who've tried at least one antiarrhythmic drug without success. It's not for those with long-term AF, related to reversible causes, recent heart issues or surgeries, very high BMI, severely reduced heart pump function, large left atrium size, or an implanted cardiac device.

What is being tested?

The study tests the Globe® Pulsed Field System's safety and effectiveness in treating atrial fibrillation. Participants will undergo this non-drug treatment designed to correct irregular heartbeats by delivering pulsed electric fields to the heart.

What are the potential side effects?

While specific side effects are not listed here, treatments like the Globe® Pulsed Field System could potentially cause discomfort at the treatment site, heartbeat irregularities during recovery and risks associated with invasive cardiac procedures.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with recurring AFib that comes and goes or stays.

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I have tried and cannot tolerate or did not respond to a heart rhythm medication.

Exclusion Criteria

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

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My atrial fibrillation is due to a temporary condition or not caused by heart disease.

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I have had a procedure done on the left side of my heart.

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I have had atrial fibrillation for more than a year.

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I have had a blood clot in the last 6 months.

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My heart's pumping ability is significantly reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

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

Treatment Details

Study Objectives

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

Primary study objectives

Effectiveness endpoint

Safety endpoint

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: Globe Pulsed Field SystemExperimental Treatment1 Intervention

0 / 7Eligibility 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

Atrial Fibrillation (AF) treatments aim to restore normal heart rhythm and control heart rate. Pharmacologic therapy uses medications like beta-blockers and calcium channel blockers to slow the heart rate, while antiarrhythmic drugs help maintain sinus rhythm. Electrical cardioversion delivers a controlled electric shock to reset the heart's rhythm. Catheter ablation, including the innovative Pulsed Field Ablation (PFA), involves creating precise lesions in heart tissue to disrupt faulty electrical pathways. PFA, as studied in the Globe® Pulsed Field System trial, uses short, high-voltage electrical pulses to target myocardial cells without damaging surrounding tissues. This specificity reduces complications and recurrence rates, making it a promising option for AF patients.

[Catheter ablation : Developments and technique selection].