N/A
N=149
A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT05752487 ↗Enrolled (actual)
149
Serious AEs
15.4%
Results posted
Oct 2024
Primary outcome: Primary: Percentage of Participants With Primary Adverse Events (PAEs) — 0.0; 0.0; 1.5; 1.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biosense Webster, Inc.
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Primary Adverse Events (PAEs) |
0.0; 0.0; 1.5; 1.5; 0.7; 0.0 | — |
| PRIMARY Percentage of Participants With Acute Procedural Success |
100 | — |
| SECONDARY Percentage of Participants With Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia |
71.6 | — |
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).
Eligibility Criteria
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 [ ) 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])
Data sourced from ClinicalTrials.gov (NCT05752487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.