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Procedure

Pulsed Field (PF)/Radiofrequency (RF) Ablation System for Atrial Fibrillation (PulseSmart Trial)

N/A

Recruiting

Research Sponsored by Biosense Webster, Inc.

Eligibility Criteria Checklist

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

Must have

Failed at least one Class I or Class III Antiarrhythmic Drug (AAD) as evidenced by recurrent symptomatic AF or intolerable side effects or contraindication to the Class I or Class III AAD

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 12

Awards & highlights

PulseSmart Trial Summary

This trial aims to show that the Biosense Webster ablation system is safe and effective in treating patients with paroxysmal atrial fibrillation by isolating the pulmonary veins.

Who is the study for?

This trial is for individuals with paroxysmal atrial fibrillation (PAF), which is an irregular heartbeat that disrupts normal blood flow. Participants must have symptoms that haven't improved with medication. Specific eligibility details are not provided, but typically participants should be adults in stable health condition.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of a new ablation system called THERMOCOOL SMARTTOUCH SF catheter paired with the TRUPULSE generator. This system aims to isolate atrial pulmonary veins to help control irregular heartbeats in PAF patients.See study design

What are the potential side effects?

While specific side effects are not listed, typical ones from catheter ablation can include discomfort at the site of insertion, bleeding or bruising, heart rhythm problems, and rarely more serious complications like stroke or heart damage.

PulseSmart Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I've had a bad reaction or no improvement from a specific heart rhythm medication.

PulseSmart Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 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 Primary Adverse Events (PAEs)

Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation (AF), Atrial Tachycardia (AT) or Atrial Flutter (AFL) of Unknown Origin) within 91-365 Days Post Index Procedure

Secondary outcome measures

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

PulseSmart Trial Design

1Treatment groups

Experimental Treatment

Group I: Pulsed Field (PF)/Radiofrequency (RF) Ablation SystemExperimental Treatment1 Intervention

Participants with drug refractory symptomatic PAF who are candidates for atrial fibrillation ablation uses PF and RF energy to produce targeted intracardiac lesions for the treatment of atrial fibrillation.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Biosense Webster, Inc.Lead Sponsor

122 Previous Clinical Trials

36,452 Total Patients Enrolled

81 Trials studying Atrial Fibrillation

28,369 Patients Enrolled for Atrial Fibrillation

Biosense Webster, Inc. Clinical TrialStudy DirectorBiosense Webster, Inc.

3 Previous Clinical Trials

5,185 Total Patients Enrolled

2 Trials studying Atrial Fibrillation

185 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.

In how many locations is this trial currently being conducted?

"Enrollment for this research study is ongoing with participation available at various sites, including Canberra Heart Rhythm in Garran, McGill University Health Centre in Montreal, and John Hunter Hospital in New Lambton Heights. Additionally, there are eight more locations where patients can enroll."

Answered by AI

Is the research trial open to individuals under 25 years of age?

"Eligible candidates for this study must be aged between 18 and 80. Notably, there are 8 trials targeting individuals under the age of 18 and an additional 486 trials focused on those over the age of 65."

Answered by AI

Do I meet the necessary criteria to participate in this medical study?

"Candidates must have a diagnosis of atrial fibrillation and fall within the age range of 18 to 80 years old to qualify for enrollment in this study. The aim is to recruit 135 participants for this trial."

Answered by AI

Is the enrollment for this study currently available to prospective participants?

"Information from clinicaltrials.gov indicates that the current trial is not actively seeking participants, as of its initial posting on March 1st, 2024 and last update on February 15th, 2024. Despite this, it's essential to note that there are a total of 489 ongoing trials open for enrollment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS

2024. "A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06272981.