NCT05752487Completed
A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator
Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
Source: ClinicalTrials.gov · Last updated 1 Jul 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 149 (actual)
- First submitted
- 22 Feb 2023
- Start date
- 27 Feb 2023
- Primary completion date
- 25 Sept 2023
- Lead sponsor
- Biosense Webster, Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT05752487
What you commit to
- Study type: Interventional
- Participants enrolled: 149
- From 27 Feb 2023 to the primary completion date, 25 Sept 2023
- 9 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous left atrium (LA) ablation or surgery
- Previously diagnosed with persistent AF \[greater than (\>) 7 days in duration\]
Lab values
- 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 \[m2\] )
Other
- 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)
- Severe dilatation of the left atrium (LA) (Left anterior descending artery \[LAD\] \>50mm antero-posterior diameter in case of Transthoracic Echocardiography \[TTE\])
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Ordensklinikum Linz GmbH Elisabethinen Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| O.L.V Ziekenhuis Coordinator of this site? Confirm its status | Aalst | Belgium | Unknown status |
| AZ Sint Jan Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Unknown status |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Gentofte Hospital Coordinator of this site? Confirm its status | Hellerup | Denmark | Unknown status |
| Vilnius University Hospital Santaros Clinics Coordinator of this site? Confirm its status | Vilnius | Lithuania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.