Globe Pulsed Field Ablation for Atrial Fibrillation

(PULSAR Trial)

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kardium Inc.

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, since it requires failure or intolerance of at least one antiarrhythmic drug, you might need to stop or have already stopped those specific medications.

What data supports the idea that Globe Pulsed Field Ablation for Atrial Fibrillation is an effective treatment?

The available research shows that Globe Pulsed Field Ablation (PFA) is a promising treatment for atrial fibrillation. Studies highlight its effectiveness and safety, with one study noting that PFA avoids damage to the esophagus, a common issue with other treatments. Another study reports successful use of PFA in real-world settings, showing it works well and is safe. These findings suggest that PFA is a good alternative to traditional methods for treating atrial fibrillation. ^{1 2 3 4 5}

What safety data exists for Globe Pulsed Field Ablation for Atrial Fibrillation?

The safety data for pulsed field ablation (PFA) systems, including those potentially related to the Globe Pulsed Field System, indicate that PFA is a promising alternative to thermal ablation for atrial fibrillation. The MANIFEST-PF survey highlights the 'real world' performance of an approved PFA catheter, noting its acute effectiveness and safety, particularly the absence of oesophageal damage. Additionally, a Good Laboratory Practice study in a porcine model characterized the chronic safety of PFA, and another study reported on the acute and 90-day safety using the CENTAURI™ System with commercial catheters. These studies collectively suggest that PFA systems have demonstrated safety in both clinical and preclinical settings. ^{1 4 5 6 7}

Is the Globe Pulsed Field System a promising treatment for atrial fibrillation?

Yes, the Globe Pulsed Field System is a promising treatment for atrial fibrillation. It uses a new type of energy that targets heart rhythm problems effectively. This method is seen as a good alternative to older treatments because it is designed to be safe and effective, with studies showing positive results in both performance and safety. ^{1 2 3 4 8}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

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

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

Exclusion Criteria

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

I have not had a heart attack or any heart procedure in the last 3 months.

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

Treatment Details

Interventions

• Globe Pulsed Field System (Procedure)

Trial Overview 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.

Participant Groups

Group I: Globe Pulsed Field System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Kardium Inc.

Lead Sponsor

Trials

7

Recruited

860+

Findings from Research

Pulsed field ablation (PFA) using the CENTAURI System achieved 100% pulmonary vein isolation in 82 patients with atrial fibrillation, demonstrating high efficacy with a first-pass isolation rate of 92.2%.

The study reported a favorable safety profile, with only four serious adverse events, indicating that optimized PFA is a viable and safe treatment option for atrial fibrillation when integrated with existing ablation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed field ablation using focal contact force-sensing catheters for treatment of atrial fibrillation: acute and 90-day invasive remapping results. Anić, A., Phlips, T., Brešković, T., et al.[2023]

Pulsed field ablation achieved a 100% pulmonary vein isolation rate in 191 atrial fibrillation patients, demonstrating its efficacy as a safe and effective treatment option.

The procedure was streamlined to reduce average procedure times significantly, from 46 minutes to 38 minutes, while maintaining safety with no further strokes and a low incidence of silent cerebral injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5S Study: Safe and Simple Single Shot Pulmonary Vein Isolation With Pulsed Field Ablation Using Sedation. Schmidt, B., Bordignon, S., Tohoku, S., et al.[2022]

Pulsed electric field (PEF) technology can effectively induce irreversible electroporation in myocardial cells, leading to cell death and potential applications in arrhythmia ablation.

Current clinical studies on various PEF catheters for atrial fibrillation ablation show promise, but further research is needed to fully establish their safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Progress in the Treatment of Tachyarrhythmia by Pulsed Electric Field Ablation Catheter Ablation]. Zhao, Z., Chen, Y., Ning, Z., et al.[2021]

Pulsed field ablation (PFA) demonstrated a strong safety profile in a study involving six pigs, with no instances of ventricular arrhythmia or other adverse events during the procedure, indicating its potential as a safe alternative for treating atrial fibrillation.

The study showed that PFA effectively created complete circumferential replacement fibrosis in targeted heart areas after 4 weeks, confirming its efficacy in achieving electrical isolation without causing thermal damage or complications like stenosis or thrombus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and chronic lesion characterization of pulsed field ablation in a Porcine model. Stewart, MT., Haines, DE., Miklavčič, D., et al.[2021]

In a study involving 1758 patients across 24 clinical centers, pulsed field ablation (PFA) demonstrated a remarkable success rate of 99.9% for pulmonary vein isolation, indicating its high efficacy in treating atrial fibrillation.

The safety profile of PFA was favorable, with no oesophageal complications reported and a low major complication rate of 1.6%, although there were still some serious risks like pericardial tamponade and stroke that need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF). Ekanem, E., Reddy, VY., Schmidt, B., et al.[2023]

Pulsed-field ablation (PFA) effectively achieved pulmonary vein isolation (PVI) in all 80 pulmonary veins of 20 patients, demonstrating its efficacy in treating atrial fibrillation.

UHDx mapping revealed that PFA creates wide and durable lesions with significant voltage reduction, although early reconnection of pulmonary veins can occur in a small percentage of cases (6.25%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed-field ablation combined with ultrahigh-density mapping in patients undergoing catheter ablation for atrial fibrillation: Practical and electrophysiological considerations. Gunawardene, MA., Schaeffer, BN., Jularic, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Pulsed field ablation using focal contact force-sensing catheters for treatment of atrial fibrillation: acute and 90-day invasive remapping results. [2023]

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

5S Study: Safe and Simple Single Shot Pulmonary Vein Isolation With Pulsed Field Ablation Using Sedation. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Progress in the Treatment of Tachyarrhythmia by Pulsed Electric Field Ablation Catheter Ablation]. [2021]

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

Safety and chronic lesion characterization of pulsed field ablation in a Porcine model. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF). [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Pulsed-Field Ablation Using a Novel Ablation-Mapping Integrated System for Pulmonary Vein Isolation-A Preliminary Animal Study. [2022]

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

Reconstruction left atrium and isolation pulmonary veins of paroxysmal atrial fibrillation using single contact force catheter with zero x-ray exposure: A CONSORT Study. [2022]

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

Pulsed-field ablation combined with ultrahigh-density mapping in patients undergoing catheter ablation for atrial fibrillation: Practical and electrophysiological considerations. [2022]