Globe Pulsed Field Ablation for Atrial Fibrillation

(PULSAR Trial)

Recruiting at 19 trial locations

Overseen By Clinical Affairs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kardium Inc.

Disqualifiers: Long-standing AF, Thromboembolic events, MI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

549 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Globe Pulsed Field System to determine its safety and effectiveness in treating atrial fibrillation (AF), a condition causing an irregular and often rapid heart rhythm. The study targets individuals with symptoms who have not found success with at least one heart rhythm medication. Those with AF lasting less than a year and who have not undergone a heart procedure in the past six months may qualify for this trial. As an unphased trial, it offers participants the chance to contribute to groundbreaking research and potentially benefit from an innovative treatment.

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must have failed or not tolerated at least one antiarrhythmic drug, which might imply changes to your medication.

What prior data suggests that the Globe Pulsed Field System is safe for treating atrial fibrillation?

Research has shown that the Globe Pulsed Field System is safe for treating atrial fibrillation (AF). Earlier studies reported no safety issues directly caused by the device, resulting in a 0% rate of device-related problems. The overall rate of safety issues was very low, at just 0.6%. Most participants tolerated the treatment well, with very few experiencing negative effects. These results support the safety of the Globe Pulsed Field System for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for atrial fibrillation, such as radiofrequency ablation or cryoablation, the Globe Pulsed Field System uses a novel approach called pulsed field ablation. This technique uses short electrical pulses to selectively target and disrupt heart tissue responsible for abnormal rhythms, potentially offering greater precision and reducing damage to surrounding tissue. Researchers are excited about this treatment because it promises to minimize complications and improve recovery times compared to conventional methods.

What evidence suggests that the Globe Pulsed Field System is effective for atrial fibrillation?

Research has shown that the Globe Pulsed Field System, which participants in this trial will receive, effectively treats atrial fibrillation (AF), a common heart condition. One study found that 78% of patients with paroxysmal AF experienced no AF symptoms or related issues a year after treatment. Another study reported that the system helped 84.2% of individuals with paroxysmal AF and 80.0% of those with persistent AF maintain a normal heart rhythm for a year. These findings suggest that the system holds promise for effectively managing AF symptoms. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Globe® Pulsed Field System procedure for atrial fibrillation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• Globe Pulsed Field System

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.

How Is the Trial Designed?

Group I: Globe Pulsed Field System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Kardium Inc.

Lead Sponsor

Trials

7

Recruited

860+

Published Research Related to This Trial

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) 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]

Ablation of paroxysmal atrial fibrillation (PAF) using a contact force (CF)-assisted catheter and a 3D mapping system without x-ray exposure was found to be safe and effective in a study involving 342 patients, with no significant differences in success rates compared to traditional x-ray methods.

The study demonstrated that while using the CF-assisted technique, the average fluoroscopy time during ablation was significantly lower (0 minutes) compared to the x-ray group (7.6 minutes), indicating a substantial reduction in radiation exposure without compromising the effectiveness of the procedure.

NCBI (Pubmed)

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. Zhang, JQ., Yu, RH., Liang, JB., et al.[2022]

The pulsed electric field (PEF) ablation system successfully isolated the pulmonary veins and superior vena cava in a study involving six pigs, demonstrating 100% effectiveness without causing muscle convulsions or damage to surrounding structures.

Histological analysis confirmed that the PFA selectively ablated heart tissue while preserving blood vessels, the esophagus, and phrenic nerves, indicating a promising safety profile for this technique in cardiac procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed-Field Ablation Using a Novel Ablation-Mapping Integrated System for Pulmonary Vein Isolation-A Preliminary Animal Study. Zhao, Z., Chen, Y., Wu, B., et al.[2022]

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) 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]

Citations

1. kardium.com kardium.com/globe-system/

Globe Pulsed Field System EFFECTIVENESS · 78% freedom from AF/AFL/AT at 1 year in patients with symptomatic paroxysmal atrial fibrillation · 100% acute pulmonary vein isolation ...

2. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)02536-0/fulltext

1-Year outcomes of the first-in-human PULSE-EU trial The 1-year Kaplan-Meier estimates of freedom from atrial arrhythmia were 84.2% (paroxysmal AF) and 80.0% (persistent AF). Conclusion. The single ...

3. kardium.com kardium.com/news/kardium-announces-1-year-pulsar-ide-study-results-for-its-pfa-device-the-globe-pf-system/

Kardium announces 1-year PULSAR IDE study results for ... “The Globe PF System achieved incredible results for safety, efficacy, durability, PFA applications and procedure times. This study is another ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05462145

Study Details | NCT05462145 | Safety and Effectiveness of ... This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9872786/

Globe Pulsed Field System for High-definition Mapping ... Catheter ablation has emerged as an effective strategy for the treatment of atrial fibrillation (AF), even becoming a first-line option for selected patients.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06973031

NCT06973031 | A Prospective Clinical Study to Evaluate ... The study will evaluate the safety and 12-month effectiveness of the Pulmonary Vein Isolation plus Box Isolation of Fibrotic Areas (BIFA) ablation strategy with ...

7. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02179-4/pdf

Late-Breaking Clinical Trials and Science The primary effectiveness endpoint was freedom from treatment failure at 12-months, and the primary safety endpoint included safety events to 6 ...