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Procedure

Catheter Ablation 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

Must not have

Previous LA ablation or surgery

Pre-existing hemi diaphragmatic paralysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 12

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had previous ablation or surgery for atrial fibrillation.

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I have paralysis on one side of my diaphragm.

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I am not pregnant, breastfeeding, or planning to become pregnant during the study.

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I have a clot or growth in my heart.

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I expect to have a major surgery, like heart surgery, within the next year.

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I have been diagnosed with narrowing of the veins in my lungs.

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I have not had a major bleeding event in the last 6 months.

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I need a procedure to destroy tissue outside the pulmonary vein area.

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I have been diagnosed with a heart rhythm problem lasting more than a week.

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My heart's pumping ability is severely reduced.

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I do not have severe or uncontrolled heart failure.

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I have a history of blood clotting or bleeding issues.

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I have had a blood clot in the last year.

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I had a heart attack or a procedure to open my heart's arteries within the last 2 months.

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I have had heart valve surgery or a procedure.

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I have a serious lung condition.

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I do not have any current infections or severe illnesses.

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I have severe leakage in my heart's mitral valve.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation

2023

N/A

~150

0 / 19Eligibility criteria met