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Pulsed Field Ablation

Participants with Paroxysmal Atrial Fibrillation (PAF) for Atrial Fibrillation (inspIRE Trial)

N/A

Waitlist Available

Research Sponsored by Biosense Webster, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 3, 6 and 12

Awards & highlights

inspIRE Trial Summary

This trial is testing whether a new heart treatment is safe and effective.

inspIRE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 3, 6 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 3, 6 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 3, 6 and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with of Primary Adverse Events (PAEs)

Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL] Greater than Equal to (>=)30 Seconds Within 91-365 days post Index Procedure

Secondary outcome measures

Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score

Number of Participants who Achieved Acute Procedural Success

Rate of Freedom from Documented Symptomatic Re-Occurrence Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) >=30 Seconds Within 91-365 days post Index Procedure

inspIRE Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with Paroxysmal Atrial Fibrillation (PAF)Experimental Treatment1 Intervention

Participants with PAF and who are candidates for catheter ablation will be enrolled.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pulsed Field Ablation (PFA) Therapy

2020

N/A

~280

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Biosense Webster, Inc.Lead Sponsor

122 Previous Clinical Trials

36,315 Total Patients Enrolled

81 Trials studying Atrial Fibrillation

28,232 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

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

Is the eligibility criterion for this experiment limited to those under 65 years of age?

"Participation in this research project is open to adults aged 18-75."

Answered by AI

Is the enrollment period still in effect for this research endeavor?

"According to clinicaltrials.gov, this trial ceased recruitment on November 28th 2022 and is no longer searching for candidates. However, there are still 477 other medical trials actively recruiting patients."

Answered by AI

What criteria need to be met in order for a person to qualify as a participant of this trial?

"To be eligible for entrance, applicants must suffer from atrial fibrillation and fall between 18-75 years old. This trial is hoping to enrol a total of 550 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)

2020. "A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04524364.