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

Biosense Webster

Status: Withdrawn

Conditions: Atrial Fibrillation

Treatments: Device: Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator

Study type: Interventional

Funder types: Industry

Identifiers

NCT06495216

BWI202304

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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])

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator

Experimental group

Description:

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.

Treatment:

Device: Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator