Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation (PFA) by Balloon Catheter With TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)

NCT ID: NCT06495216

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-17
• Study Completion Date: 2025-12-26

Brief Summary

The purpose of this study is to explore preliminary safety and acute effectiveness of pulsed field ablation by the ablation system (pulsed field ablation balloon catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator

Participants with paroxysmal atrial fibrillation (PAF) will undergo pulmonary vein (PV) ablation procedure with investigational system (pulsed field ablation balloon catheter used in combination with the TRUPULSE generator) until pulmonary vein isolation (PVI) is achieved and confirmed via entrance block. If PVI cannot be achieved with the investigational system, a commercially approved Biosense Webster (recommended) catheter and compatible commercially available generator can be used to complete the procedure.

Group Type: EXPERIMENTAL

Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator

Intervention Type: DEVICE

Pulsed field ablation balloon catheter and TRUPULSE generator will be used for PV ablation.

Interventions

Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator

Pulsed field ablation balloon catheter and TRUPULSE generator will be used for PV ablation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosed with symptomatic Paroxysmal Atrial Fibrillation (PAF) defined as AF that terminates spontaneously or with intervention within 7 days of onset. This PAF is considered to be symptomatic if symptoms related to AF are experienced by the participant
• Selected for AF ablation procedure by pulmonary vein isolation (PVI)
• Willing and capable of providing consent
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria

• Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity [body mass index more than {>} 40 kilogram per square meter {kg/m^2}], renal insufficiency [with an estimated creatinine clearance less than {<}30 milliliter {mL}/minute {min}/1.73 meter {m}^2])
• Previous left atrium (LA) ablation or surgery
• Participants known to require ablation outside the pulmonary vein (PV) region (example, atrioventricular reentrant tachycardia, atrioventricular nodal re-entry tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
• Previously diagnosed with persistent AF (>7 days in duration)
• Severe dilatation of the LA (left anterior descending artery [LAD] >50 millimetre [mm] antero-posterior diameter or left atrium volume index [LAVi] >48 [mL/m^2] in case of transthoracic echocardiography [TTE])

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Biosense Webster, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Biosense Webster, Inc.

Other Identifiers

BWI202304

Identifier Type: -

Identifier Source: org_study_id