Atrial FibrillationSmartfIRENCT05752487
A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator
A study testing Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 9 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 27 Feb 2023to 17 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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])
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Belgium4 sites
O L V Ziekenhuis
Aalst, 9300
AZ Sint-Jan
Bruges, 8000
Ziekenhuis Oost-Limburg
Genk, 3600
Jessa Ziekenhuis
Hasselt, 3500
Austria2 sites
Medical University Graz
Graz, 8036
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020
Denmark2 sites
Aarhus University Hospital
Aarhus, 8200
Gentofte Hospital
Hellerup, 2900
About this study
Official title: Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
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).
- Conditions
- Atrial Fibrillation
- Being tested
- Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Field (PF) /Radiofrequency (RF) Catheter ablationDevice
Participants will undergo catheter ablation with the PF /RF ablation system consisting of the TRUPULSE Generator (delivers RF or PF energy through the study catheter) and the THERMOCOOL SMARTTOUCH SF (STSF) Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a Generator, for cardiac ablation).
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation | Experimental | Participants with drug refractory, paroxysmal atrial fibrillation (PAF) who are candidates for catheter ablation will be enrolled with ablation system which uses THERMOCOOL SMARTTOUCH SF (STSF) catheter and TRUPULSE generator to deliver RF or PF energy during cardiac ablation procedures. Receives: Device: Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Primary Adverse Events (PAEs)
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.
Measured: 90 days post-procedure on Day 1
Percentage of Participants With Acute Procedural Success
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.
Measured: Immediately post-procedure on Day 1
Secondary outcomes (1)
Percentage of Participants With Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia
Percentage of participants with freedom from documented (symptomatic and asymptomatic) atrial arrhythmia episodes including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; unknown origin) episodes based on electrocardiographic data (greater than equal to [>=]30 seconds on arrhythmia monitoring device) were reported. Participants with an AF/AT/AFL (of unknown origin) episode that is >=30 seconds on arrhythmia monitoring device during the evaluation period were considered failures of this long-term effectiveness outcome measure. Acute procedural failure (that is, failure to achieve entrance block with the study device in any of the targeted pulmonary vein [PVs]) were also deemed a failure of this outcome measure. AFL of unknown origin was defined as all AFL except those cavotricuspid isthmus (CTI) dependent AFL as confirmed by 12-lead electrocardiogram (ECG) or entrainment maneuvers in an electrophysiology (EP) study.
Measured: Day 91 to Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start27 Feb 2023
- Primary completion25 Sep 2023
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Biosense Webster, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Biosense Webster, Inc. Clinical Trial, Study director, Biosense Webster, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752487
- Sponsor's protocol ID
- BWI202202
- Other IDs
- BWI202202
- Acronym
- SmartfIRE
- Status last verified
- Jun 2025
- First submitted
- 22 Feb 2023
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
Publications
De Potter T, Scherr D, Purerfellner H, Rackauskas G, Hansen J, Vijgen J, Phlips T, Knecht S, Szeplaki G, Van Herendael H, Kronborg MB, Berte B, Ruwald M, Kollias G, Lukac P, Tan T, Duytschaever M. Dual energy for pulmonary vein isolation using focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 12-month results. Europace. 2025 Sep 1;27(9):euaf174. doi: 10.1093/europace/euaf174.
PubMed 40796332Duytschaever M, Rackauskas G, De Potter T, Hansen J, Knecht S, Phlips T, Vijgen J, Scherr D, Szeplaki G, Van Herendael H, Kronborg MB, Berte B, Purerfellner H, Lukac P. Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results. Europace. 2024 May 2;26(5):euae088. doi: 10.1093/europace/euae088.
PubMed 38696675
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
- ClinicalTrials.gov ID
- NCT05752487
- Acronym / sponsor ID
- SmartfIRE / BWI202202
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Posted 16 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation | Experimental | Device: Pulsed Field (PF) /Radiofrequency (RF) Catheter ablationParticipants with drug refractory, paroxysmal atrial fibrillation (PAF) who are candidates for catheter ablation will be enrolled with ablation system which uses THERMOCOOL SMARTTOUCH SF (STSF) catheter and TRUPULSE generator to deliver RF or PF energy during cardiac ablation procedures. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Field (PF) /Radiofrequency (RF) Catheter ablationParticipants will undergo catheter ablation with the PF /RF ablation system consisting of the TRUPULSE Generator (delivers RF or PF energy through the study catheter) and the THERMOCOOL SMARTTOUCH SF (STSF) Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a Generator, for cardiac ablation). | Device | Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation |
Primary outcome
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.
1 secondary outcome
Percentage of Participants With Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia
Time frame: Day 91 to Day 365
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40796332De Potter T, Scherr D, Purerfellner H, Rackauskas G, Hansen J, Vijgen J, Phlips T, Knecht S, Szeplaki G, Van Herendael H, Kronborg MB, Berte B, Ruwald M, Kollias G, Lukac P, Tan T, Duytschaever M. Dual energy for pulmonary vein isolation using focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 12-month results. Europace. 2025 Sep 1;27(9):euaf174. doi: 10.1093/europace/euaf174.
- Derived from this study: PubMed 38696675Duytschaever M, Rackauskas G, De Potter T, Hansen J, Knecht S, Phlips T, Vijgen J, Scherr D, Szeplaki G, Van Herendael H, Kronborg MB, Berte B, Purerfellner H, Lukac P. Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results. Europace. 2024 May 2;26(5):euae088. doi: 10.1093/europace/euae088.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biosense Webster, Inc. Clinical Trial study director
Biosense Webster, Inc.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium, Austria, Denmark, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Primary Adverse Events (PAEs) (time frame: 90 days post-procedure on Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05752487, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.