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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis - Campus Virga Jesse
  • Jette, Belgium, 1090
    • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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])

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Primary Adverse Events (PAEs)	Percentage of participants with PAEs will be reported. PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, severe pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.	Up to 3 months post-procedure
Percentage of Participants with Acute Effectiveness	Percentage of participants with acute effectiveness will be reported. Acute effectiveness is an electrical isolation of clinically relevant targeted pulmonary veins (PVs) which is evidenced by confirmation of entrance block, after adenosine/isoproterenol challenge, at the end of the index ablation procedure.	Up to 3 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of Unknown Origin) Episodes During the Effectiveness Evaluation Period	Percentage of participants with freedom from documented (symptomatic and asymptomatic) atrial arrhythmia (AF, AT or AFL of unknown origin) episodes based on electrocardiographic data (more than equal to [>=]30 seconds on arrhythmia monitoring device) during the effectiveness evaluation period (Day 91 to Day 365) on or off antiarrhythmic therapy will be reported. Acute procedural failure (that is, failure to achieve entrance block with the study device in any of the clinically relevant targeted PVs) will also be deemed a 12-month effectiveness failure.	Within Day 91 to Day 365
Percentage of PVs that are Targeted in the Index Ablation Procedure with Sustained Isolation at Day 75	Percentage of PVs that are targeted in the index ablation procedure with sustained isolation, which is evidenced by electrical confirmation (through pacing for entrance block) of isolation at Day 75 post index ablation procedure will be reported.	Day 75

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Study Director: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): August 17, 2024
• Primary Completion (Estimated): March 26, 2025
• Study Completion (Estimated): December 26, 2025

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: BWI202304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No