Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Biosense Webster, Inc.
- Enrollment
- 149
- Locations
- 18
- Primary Endpoint
- Percentage of Participants With Primary Adverse Events (PAEs)
Study Overview
Brief Summary
The purpose of this study is to demonstrate safety and effectiveness of the ablation system (THERMOCOOL SMARTTOUCH SF [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) defined as atrial fibrillation (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)
- •Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced by recurrent symptomatic AF, or intolerable or contraindicated to the AAD
- •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 greater than [>] 40 kilograms per meter square [kg/m²]}, renal insufficiency (with an estimated creatinine clearance less than [<] 30 milliliters [mL]/ minute [min]/1.73 meter square [m2] )
- •Previous left atrium (LA) ablation or surgery
- •Patients known to require ablation outside the pulmonary vein (PV) region (example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, ventricular tachycardia and wolff-parkinson-white)
- •Previously diagnosed with persistent AF [greater than (>) 7 days in duration]
- •Severe dilatation of the left atrium (LA) (Left anterior descending artery [LAD] >50mm antero-posterior diameter in case of Transthoracic Echocardiography [TTE])
Outcomes
Primary Outcomes
Percentage of Participants With Primary Adverse Events (PAEs)
Time Frame: 90 days post-procedure on Day 1
Percentage of participants with PAEs (within 7 days following the ablation procedure) was reported. PAEs included the following adverse events atrio-esophageal fistula, pulmonary vein stenosis, device or procedure related death, (that occurred greater than 7 days and less than or equal to 90 days post-procedure), phrenic nerve paralysis (permanent), cardiac tamponade/perforation, 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 Procedural Success
Time Frame: Immediately post-procedure on Day 1
Percentage of participants with acute procedural success were reported. Procedural success was defined as electrical isolation of clinically relevant targeted pulmonary veins (PVs) (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure.
Secondary Outcomes
- Percentage of Participants With Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia(Day 91 to Day 365)