Paroxysmal Atrial FibrillationSTSFNCT03963349
THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study
An observational study of Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc. at 1 site in China.
Trial summary
A single-center, real word study of consecutive subjects who undergo radiofrequency ablation for paroxysmal AF using THERMOCOOL SMARTTOUCH®SF (STSF) Catheter guiding by Ablation Index (AI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2019to 31 Dec 2026
- How long will I take part?
- 1 Year
- 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: PAF population patients
Who may be able to join
- Age 18 years or older
- Patient has PAF eligible for AI-guided catheter ablation with an STSF catheter per standard of care assessment
- Able and willing to comply with all pre-, post- and follow-up testing and requirements
- Able to sign EC-approved informed consent form
Who cannot join
- AF is secondary to electrolyte imbalance, thyroid disease, or a reversible or non-cardiac cause
- Patient has AF episodes lasting longer than 7 days
- History of heart surgery, or any previous ablation for AF
- Myocardial infarction (MI), coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within preceding 3 months
- Documented left atrial thrombus on imaging
- New York Heart Association (NYHA) class III or IV heart failure
Show all 12Show fewer
- Hypertrophic obstructive cardiomyopathy
- Presence of implantable cardioverter defibrillator (ICD)
- Contraindication to isoproterenol
- Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator
- Women who are pregnant and/or breast feeding
- Enrollment in an investigational study evaluating another device, biologic, or drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Benefit, Long Term Effectiveness, and Safety Outcome of Paroxysmal Atrial Fibrillation Ablation Using THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index
A single-center, real word study of consecutive subjects who undergo radiofrequency ablation for paroxysmal AF using THERMOCOOL SMARTTOUCH®SF (STSF) Catheter guiding by Ablation Index (AI). Prospectively or retrospectively record 150 eligible subjects since 1st Jan 2019 to evaluate effectiveness and safety of STSF with AI.
Read the detailed description
The purpose of this study is to measure the long term effectiveness，clinical benefit, and safety outcomes of catheter ablation with STSF and AI for paroxysmal atrial fibrillation (PAF) subjects up to 12-month follow-up.
Subject:Up to 150 PAF subjects will be included in the study data, representing all consecutive subjects having catheter ablation with AI guiding STSF and for the treatment of PAF at the site.
Primary endpoint: The primary endpoint is freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure.
Secondary endpoint : Acute success at 0.5hour CPVI (i.e. entrance block achieved in all veins, verified via an isoproterenol intravenous challenge)
- Numbers of reconnected pulmonary veins (PV), with number and location of any gaps
- Procedural efficiency measures（e.g. mapping time, ablation time, total procedure time, and fluid volume delivered via catheter.
- AI values
- Inter-Tag distances
- Adverse events (Complications related to device or procedure)
- Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year Clinical Study Sites: Shanghai General Hospital Study Duration: 18-month enrollment period, with follow-up at 3, 6 and 12 months after ablation, with a blanking period defined as the period within 90 days after the ablation.
- Conditions
- Paroxysmal Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure.
Atrial tachyarrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.
Measured: 91-365 days
Secondary outcomes (12)
Rate of acute success at 0.5hour CPVI
Entrance block rate achieved by all pulmonary veins after 0.5hour waiting time and isoproterenol challenge after CPVI
Measured: 91-365 days
Numbers of reconnected pulmonary veins (PV), with number and location of any gaps
Numbers of pulmonary veins recovered after 0.5hour waiting time and isoproterenol challenge after CPVI, and the location of recovery and number are also recorded
Measured: 91-365 days
Mapping time
Procedural efficiency measures
Measured: 91-365 days
Contact force in grams
Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation
Measured: 91-365 days
Rate of adverse events occurred
Complications related to device or procedure
Measured: 91-365 days
Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year
Rate of patients who are back to hospital and got hospitalized due to AF/AT/AFL recurrence or procedure-related reasons during 91 to 365 days after procedure
Measured: 91-365 days
Ablation time
Procedural efficiency measures
Measured: 91-365 days
Total procedure time
Procedural efficiency measures
Measured: 91-365 days
Fluid volume delivered via catheter
Procedural efficiency measures
Measured: 91-365 days
Ablation times in seconds
Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation
Measured: 91-365 days
Inter Tag in micrometers
Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation
Measured: 91-365 days
RF ablation and fluoroscopy times in seconds
Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation
Measured: 91-365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start24 Jun 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaowen Liu, PhD, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963349
- Sponsor's protocol ID
- BWI-2018-01
- Acronym
- STSF
- Status last verified
- Sep 2026
- First submitted
- 6 May 2019
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Benefit, Long Term Effectiveness, and Safety Outcome of Paroxysmal Atrial Fibrillation Ablation Using THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index
- ClinicalTrials.gov ID
- NCT03963349
- Acronym / sponsor ID
- STSF / BWI-2018-01
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 May 2019 (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.
A single-center, real word study of consecutive subjects who undergo radiofrequency ablation for paroxysmal AF using THERMOCOOL SMARTTOUCH®SF (STSF) Catheter guiding by Ablation Index (AI). Prospectively or retrospectively record 150 eligible subjects since 1st Jan 2019 to evaluate effectiveness and safety of STSF with AI.
Detailed description
The purpose of this study is to measure the long term effectiveness，clinical benefit, and safety outcomes of catheter ablation with STSF and AI for paroxysmal atrial fibrillation (PAF) subjects up to 12-month follow-up.
Subject:Up to 150 PAF subjects will be included in the study data, representing all consecutive subjects having catheter ablation with AI guiding STSF and for the treatment of PAF at the site.
Primary endpoint: The primary endpoint is freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure.
Secondary endpoint : Acute success at 0.5hour CPVI (i.e. entrance block achieved in all veins, verified via an isoproterenol intravenous challenge)
- Numbers of reconnected pulmonary veins (PV), with number and location of any gaps
- Procedural efficiency measures（e.g. mapping time, ablation time, total procedure time, and fluid volume delivered via catheter.
- AI values
- Inter-Tag distances
- Adverse events (Complications related to device or procedure)
- Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year Clinical Study Sites: Shanghai General Hospital Study Duration: 18-month enrollment period, with follow-up at 3, 6 and 12 months after ablation, with a blanking period defined as the period within 90 days after the ablation.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PAF population patients
Key inclusion criteria (4 listed)
- Age 18 years or older
- Patient has PAF eligible for AI-guided catheter ablation with an STSF catheter per standard of care assessment
- Able and willing to comply with all pre-, post- and follow-up testing and requirements
- Able to sign EC-approved informed consent form
Key exclusion criteria (12 listed)
- AF is secondary to electrolyte imbalance, thyroid disease, or a reversible or non-cardiac cause
- Patient has AF episodes lasting longer than 7 days
- History of heart surgery, or any previous ablation for AF
- Myocardial infarction (MI), coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within preceding 3 months
- Documented left atrial thrombus on imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure.
Time frame: 91-365 days
Atrial tachyarrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.
12 secondary outcomes
Rate of acute success at 0.5hour CPVI
Time frame: 91-365 days
Numbers of reconnected pulmonary veins (PV), with number and location of any gaps
Time frame: 91-365 days
Mapping time
Time frame: 91-365 days
Contact force in grams
Time frame: 91-365 days
Rate of adverse events occurred
Time frame: 91-365 days
Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year
Time frame: 91-365 days
Ablation time
Time frame: 91-365 days
Total procedure time
Time frame: 91-365 days
Fluid volume delivered via catheter
Time frame: 91-365 days
Ablation times in seconds
Time frame: 91-365 days
Inter Tag in micrometers
Time frame: 91-365 days
RF ablation and fluoroscopy times in seconds
Time frame: 91-365 days
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 28 Sep 2026.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://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.
Shaowen Liu, PhD principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site 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, run by Biosense Webster, Inc. at 1 site in China.
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 12 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 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Rate of freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure. (time frame: 91-365 days). 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 28 Sep 2026.