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

NCT06495216 | Withdrawn

• 1 other identifier: BWI202304
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

  Within Day 91 to Day 365

• Percentage of PVs that are Targeted in the Index Ablation Procedure with Sustained Isolation at Day 75

  Day 75

Study Arms (1)

Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator

EXPERIMENTAL

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

Interventions

Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator DEVICE

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

Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 \[TTE\])

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Biosense Webster, Inc. Clinical Trial

  Biosense Webster, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 10, 2024
• Study Start: August 17, 2024
• Primary Completion: March 26, 2025
• Study Completion: December 26, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share