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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

PULSAR Trial Summary

This trial will test a new device to treat atrial fibrillation, to see if it 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.Check my eligibility
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.See study design
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.

PULSAR Trial Eligibility Criteria

Inclusion Criteria

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

PULSAR Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness endpoint
Safety endpoint

PULSAR Trial Design

1Treatment groups
Experimental Treatment
Group I: Globe Pulsed Field SystemExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Kardium Inc.Lead Sponsor
6 Previous Clinical Trials
382 Total Patients Enrolled
5 Trials studying Atrial Fibrillation
290 Patients Enrolled for Atrial Fibrillation

Media Library

Globe Pulsed Field System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05462145 — N/A
Atrial Fibrillation Research Study Groups: Globe Pulsed Field System
Atrial Fibrillation Clinical Trial 2023: Globe Pulsed Field System Highlights & Side Effects. Trial Name: NCT05462145 — N/A
Globe Pulsed Field System (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05462145 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will elderly patients be included in the research?

"The recruitment process for this study seeks out patients that are over 18 and younger than 80 years old."

Answered by AI

Can new research participants join this clinical trial?

"Data from clinicaltrials.gov verifies that this trial is not enrolling patients at the moment. The trial was initially posted on December 1st, 2022 and was last updated on July 15th, 2022. Although this particular trial isn't looking for volunteers right now, there are 500 other clinical trials with open enrollment."

Answered by AI

For which type of patient is this research project recruiting?

"We are looking for 435 patients with paroxysmal atrial fibrillation who also meet the following requirements: AAD Class I or III intolerance, recurrent symptomatic paroxysmal or persistent AF, and Key."

Answered by AI

Who else is applying?

What site did they apply to?
Beaumont Hospital
Sutter Health - California Pacific Medical Center
Cleveland Clinic
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Tried beta blockers, flecainide in combo with diltiazem; could not tolerate. Using diltiazem alone, some side effects. Want to be as free as I can of worry about AF recurrence. Think that pulsed field ablation will be the technology of the future.
PatientReceived 2+ prior treatments
Have tried drugs; found flecainide intolerable; diltiazem tolerable but with side effects I would rather not have. Would like to semi- if not permanently end the worry of AF recurrence. Am of the opinion that pulsed field ablation is the way of the future,.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Roughly speaking and presuming inclusion criteria met, when would procedure be performed?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
2023. "Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05462145.
~184 spots leftby Feb 2025
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