Clinical trial NCT06495216: Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation (PFA) by Balloon Catheter With TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
Official title: Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation by a Balloon Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 \[TTE\])

Primary outcomes:
measure: Percentage of Participants with Primary Adverse Events (PAEs)
timeFrame: Up to 3 months post-procedure
measure: Percentage of Participants with Acute Effectiveness
timeFrame: Up to 3 months post-procedure
Secondary outcomes:
measure: 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
timeFrame: Within Day 91 to Day 365
measure: Percentage of PVs that are Targeted in the Index Ablation Procedure with Sustained Isolation at Day 75
timeFrame: Day 75
Other outcomes:
Locations:
Study officials:
affiliation: Biosense Webster, Inc.
name: Biosense Webster, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: