Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation by a Balloon Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Biosense Webster, Inc.
- Enrollment
- 30
- Primary Endpoint
- Percentage of Participants with Primary Adverse Events (PAEs)
- Status
- Withdrawn
- Last Updated
- last year
Overview
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.
Investigators
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 \[TTE\])
Outcomes
Primary Outcomes
Percentage of Participants with Primary Adverse Events (PAEs)
Time Frame: Up to 3 months post-procedure
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.
Percentage of Participants with Acute Effectiveness
Time Frame: Up to 3 months post-procedure
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.
Secondary Outcomes
- Percentage of PVs that are Targeted in the Index Ablation Procedure with Sustained Isolation at Day 75(Day 75)
- 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)