Paroxysmal Atrial Fibrillation (PAF)First LineNCT07092774
Real-world Safety and Effectiveness Registry of Catheter Ablation of Paroxysmal Atrial Fibrillation as Initial Control Therapy With the Thermocool SmartTouch SF Catheter (A Sub-study of REAL AF Registry)
An observational study of Paroxysmal Atrial Fibrillation (PAF), run by Heart Rhythm Clinical and Research Solutions, LLC at 12 sites in United States.
Trial summary
To generate real-world evidence from the parent study, REAL AF registry, on the use of Thermocool SmartTouch SF (STSF) catheter in ablation for the treatment of paroxysmal atrial fibrillation (PAF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation (PAF)
- What is being tested?
- Ablation
- Type of treatment
- Medical device
- How many people
- 344 participants
- Where
- 12 sitesUnited States
- Study dates
- 1 Apr 2024to Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sub-study population will consist of Class I/III AAD naïve PAF patients who underwent ablation procedure using the THERMOCOOL STSF Catheter as their first rhythm control therapy. The study will include consecutive, eligible patients from the REAL AF registry, starting from October 2021, who meet the sub-study eligibility criteria until 344 eligible subjects are identified. Eligible patients from all participating centers in the REAL AF registry will be included, except for sites with standard-of-care rhythm monitoring less than 48 hours, and those that do not perform 6-12 months follow-up as standard-of-care.
Who may be able to join
- Diagnosed with symptomatic PAF
- First time ablation
- Ablation performed with the Thermocool STSF catheter
- Age 18 or over at the time of the index ablation procedure
Who cannot join
- Received Class I or III antiarrhythmic drug prior to the index ablation.
- Did not previously consent for their anonymized data to be used for research purposes.
- Rhythm monitoring less than 48 hours.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Arrhythmia Institute at Grandview
Birmingham, Alabama, 35243
Mount Carmel Columbus Cardiology Consultants
Columbus, Ohio, 43213
Northshore University Health System
Evanston, Illinois, 60201
Upstate Cardiology
Greenville, South Carolina, 29607
Ascension St. Vincent's Hospital
Indianapolis, Indiana, 46260
Ascension St. Vincent's
Jacksonville, Florida, 32204
Centra Health, Inc. (dba Stroobants Cardiovascular Center)
Lynchburg, Virginia, 24501
University of Pennsylvania, Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Allegheny Health Network
Pittsburgh, Pennsylvania, 15222
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Community Memorial Hospital
Ventura, California, 93303
Michigan Heart
Ypsilanti, Michigan, 48197
About this study
Official title: Real-World Safety and Effectiveness of Catheter Ablation of Paroxysmal Atrial Fibrillation as Initial Rhythm Control Therapy With the THERMOCOOL SMARTTOUCH SF Catheter - A Sub-study of REAL AF Registry
To generate real-world evidence from the parent study, REAL AF registry, on the use of Thermocool SmartTouch SF (STSF) catheter in ablation for the treatment of paroxysmal atrial fibrillation (PAF).
Read the detailed description
The primary objective of this registry is to evaluate effectiveness and safety of Thermocool STSF catheter to support an indication extension of the STSF catheter using real world data from the REAL AF registry. Subjects included in the registry will be those in which the STSF catheter is used for the treatment of symptomatic PAF in antiarrhythmic drug (AAD) naive patients as an initial rhythm control therapy. The registry will involve retrospective analysis of data prospectively collected from the REAL AF registry. The registry will include consecutive, eligible patients from the REAL AF registry, starting from October 2021 who meet the sub-study eligibility criteria until 344 eligible subjects are identified. Eligible patients from all participating centers in the REAL AF registry will be included, except for sites with standard-of-care rhythm monitoring less than 48 hours and those that do not perform 6-12 month follow up as standard of care.
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Being tested
- 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.
AblationDevice
Ablation procedure using the Thermocool Smarttouch SF
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary effectiveness
Freedom from atrial arrhythmia recurrence
Measured: 12-months
Primary effectiveness
Any repeat ablation procedure, use of class I/III AAD, or cardioversion post-blanking for treatment of atrial arrhythmia will be deemed failure of primary effectiveness endpoint.
Measured: Post 3-month blanking period
Primary safety
A composite of procedure or device related adverse events post index ablation.
Measured: 7 days
Primary safety
Atrio-esophageal fistula, severe pulmonary vein stenosis and device or procedure related death post index ablation
Measured: 90 days
Primary safety
Cardiac tamponade/pericardial effusion post index ablation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Apr 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial Fibrillation (PAF)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 344 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092774
- Sponsor's protocol ID
- BWI-CS-004-F
- Acronym
- First Line
- Status last verified
- Oct 2025
- First submitted
- 22 Jul 2025
- Last updated
- 31 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Safety and Effectiveness of Catheter Ablation of Paroxysmal Atrial Fibrillation as Initial Rhythm Control Therapy With the THERMOCOOL SMARTTOUCH SF Catheter - A Sub-study of REAL AF Registry
- ClinicalTrials.gov ID
- NCT07092774
- Acronym / sponsor ID
- First Line / BWI-CS-004-F
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLCUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To generate real-world evidence from the parent study, REAL AF registry, on the use of Thermocool SmartTouch SF (STSF) catheter in ablation for the treatment of paroxysmal atrial fibrillation (PAF).
Detailed description
The primary objective of this registry is to evaluate effectiveness and safety of Thermocool STSF catheter to support an indication extension of the STSF catheter using real world data from the REAL AF registry. Subjects included in the registry will be those in which the STSF catheter is used for the treatment of symptomatic PAF in antiarrhythmic drug (AAD) naive patients as an initial rhythm control therapy. The registry will involve retrospective analysis of data prospectively collected from the REAL AF registry. The registry will include consecutive, eligible patients from the REAL AF registry, starting from October 2021 who meet the sub-study eligibility criteria until 344 eligible subjects are identified. Eligible patients from all participating centers in the REAL AF registry will be included, except for sites with standard-of-care rhythm monitoring less than 48 hours and those that do not perform 6-12 month follow up as standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sub-study population will consist of Class I/III AAD naïve PAF patients who underwent ablation procedure using the THERMOCOOL STSF Catheter as their first rhythm control therapy. The study will include consecutive, eligible patients from the REAL AF registry, starting from October 2021, who meet the sub-study eligibility criteria until 344 eligible subjects are identified. Eligible patients from all participating centers in the REAL AF registry will be included, except for sites with standard-of-care rhythm monitoring less than 48 hours, and those that do not perform 6-12 months follow-up as standard-of-care.
Key inclusion criteria (4 listed)
- Diagnosed with symptomatic PAF
- First time ablation
- Ablation performed with the Thermocool STSF catheter
- Age 18 or over at the time of the index ablation procedure
Key exclusion criteria (3 listed)
- Received Class I or III antiarrhythmic drug prior to the index ablation.
- Did not previously consent for their anonymized data to be used for research purposes.
- Rhythm monitoring less than 48 hours.
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 |
|---|---|---|
| AblationAblation procedure using the Thermocool Smarttouch SF | Device | – |
Primary outcome
Primary effectiveness
Time frame: 12-months
Freedom from atrial arrhythmia recurrence
Primary effectiveness
Time frame: Post 3-month blanking period
Any repeat ablation procedure, use of class I/III AAD, or cardioversion post-blanking for treatment of atrial arrhythmia will be deemed failure of primary effectiveness endpoint.
Primary safety
Time frame: 7 days
A composite of procedure or device related adverse events post index ablation.
Primary safety
Time frame: 90 days
Atrio-esophageal fistula, severe pulmonary vein stenosis and device or procedure related death post index ablation
Primary safety
Time frame: 30 days
Cardiac tamponade/pericardial effusion post index ablation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Atrial Fibrillation (PAF), run by Heart Rhythm Clinical and Research Solutions, LLC at 12 sites in United States.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Primary effectiveness (time frame: 12-months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2025.