Atrial FibrillationDualSmartNCT07845682
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With TRUPULSE™ Generator in Persistent Atrial Fibrillation
A study testing Radiofrequency/Pulsed Field Ablation in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 4 sites in China.
Trial summary
This purpose of this study is to understand how safe Biosense Webster Pulsed Field (PF)/Radiofrequency (RF) ablation system is and how well it works over 12 months in participants with persistent atrial fibrillation (PsAF; abnormal heart signals that cause irregular heartbeats). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Radiofrequency/Pulsed Field Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesChina
- Study dates
- 14 Oct 2026to 17 Apr 2028
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented symptomatic persistent atrial fibrillation (AF), which is defined as continuous AF that sustains beyond 7 days and less than 1 year and is documented by the following: Physician's note indicating continuous AF greater than or equal to (>=) 7 days but no more than 1 year; AND 1) Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart (electrograms cannot >12 months prior to enrollment) OR 2) At least 24-hour Holter/ telemetry strip within 12 months prior to enrollment showing continuous AF
- Failed at least one (1) antiarrhythmic drug (AAD) (Class I or Class III) as evidenced by recurrent symptomatic AF, intolerable to the AAD
- Age 18-80 years
- Willing and capable of providing consent
- Able and willing to comply with all pre-, post- and follow-up testing and requirement
Who cannot join
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, etcetera)
- Documented severe dilatation of the left atrium (LA) (LAD >50 millimetre [mm]) antero-posterior diameter on imaging within 6 months prior to procedure
- Documented severely compromised left ventricular ejection fraction (LVEF) (LVEF less than [<] 40 percent [%]) by imaging within 6 months prior to procedure
- Severe mitral regurgitation or insufficiency, or the report claims: Regurgitant volume >=60 millilitre (mL)/beat, Regurgitant fraction >=50%, and/or effective regurgitant orifice area >=0.40 square centimetre (cm^2).
- Moderate-severe, severe tricuspid valve regurgitation or insufficiency
- Documented LA thrombus by imaging within 48 hours of the procedure or by intracardiac echocardiography (ICE) prior to transeptal puncture during procedure
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- Concomitant other arrhythmia, including: atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial flutter of unknown origin, ventricular tachycardia and Wolff-Parkinson-Whiteexcept cavotricuspid isthmus (CTI) lines for the ablation of typical right atrial flutter
- Previous LA ablation or surgery
- Valvular cardiac surgical/percutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)
- Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
- Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
- History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, etcetera)
- Documented thromboembolic event (including transient ischemic attack [TIA]) within the past 12 months
- History of a documented symptomatic lacunar infarction within the past 12 months
- Participants with percutaneous coronary intervention or acute myocardial infarction within 3 months
- Coronary artery bypass grafting (CABG) surgery within the past 6 months (180 days)
- Unstable angina within the past 6 months
- Significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- Significant congenital anomaly (for example, american society for dermatologic surgery [ASDs]) including treated or medical problem that in the opinion of the investigator would preclude enrollment in this study
- Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
- Presence of a condition that precludes vascular access
- Prior diagnosis of pulmonary vein stenosis
- Pre-existing hemi diaphragmatic paralysis
- Acute illness, active systemic infection, or sepsis
- Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, etcetera) (this exclusion does not include coronary stents, implanted pacemakers, implantable cardioverter-defibrillators [ICD] and implantable loop recorders [ILR])
- Current enrollment in an investigational study evaluating another device or drug
- Women who are pregnant (as evidenced by pregnancy test if pre- menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
- Life expectancy less than 12 months
- History of massive haemorrhage within the past 6 months
- Those considered by the investigators as not suitable for participating in this clinical study
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, 101118
- Recruiting
Qilu Hospital of Shandong University
Jinan, 250063
- Recruiting
Jiangsu Province Hospital
Nanjing, 210029
- Recruiting
Shanghai Chest Hospital
Shanghai, 200030
About this study
Official title: A Prospective, Multicenter, Single Arm With Performance Goal Study to Evaluate Safety and Effectiveness of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator in Persistent Atrial Fibrillation (PsAF)
This purpose of this study is to understand how safe Biosense Webster Pulsed Field (PF)/Radiofrequency (RF) ablation system is and how well it works over 12 months in participants with persistent atrial fibrillation (PsAF; abnormal heart signals that cause irregular heartbeats).
- Conditions
- Atrial Fibrillation
- Being tested
- Radiofrequency/Pulsed Field 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.
Radiofrequency/Pulsed Field AblationDevice
Radiofrequency and pulsed field ablation by Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter with the TRUPULSE™ generator will be used.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency/Pulsed Field Ablation | Experimental | Participants with persistent atrial fibrillation (PsAF) will undergo catheter ablation using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter in combination with the TRUPULSE™ generator according to the study procedural workflow. Receives: Device: Radiofrequency/Pulsed Field Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (that is, atrial fibrillation or atrial tachycardia or atrial flutter [AF, AT or AFL] of unknown origin) episodes based on electrocardiographic data and freedom from acute procedural failure, repeat ablation failure, non-study device failure, antiarrhythmic drug (AAD) failure, continuous AF/AT/AFL of unknown origin, and any direct current (DC) cardioversion procedure will be reported.
Measured: Day 91 up to Day 365 post index procedure
Occurrence of Early Onset Primary Adverse Event (PAE)
PAEs include the following Adverse Events (AEs): esophageal perforating complications (Atrio-esophageal fistula occuring up to 90 days post ablation procedure); phrenic nerve paralysis; cardiac Tamponade, perforation (occuring up to 30 days post ablation procedure); pulmonary vein stenosis (anytime during the 12 month follow up period); device or procedure related death (anytime during or after the ablation procedure); stroke/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: Within 7 days post index procedure
Secondary outcomes (1)
Change From Baseline in Quality of life, As Measured by the Total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score at 12 Months Post Procedure
The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 20 to 140. A score of 140 represents extreme distress (or extreme limitation, dissatisfaction or difficulty), while a score of 20 corresponds to no disability (or responding "not at all" limited, difficult or extreme satisfaction).
Measured: Baseline, At 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start14 Oct 2026
- Primary completion17 Apr 2028 (estimated)
- Study completion17 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 150 participants (estimated)
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
- NCT07845682
- Sponsor's protocol ID
- BWI202507
- Other IDs
- BWI202507
- Acronym
- DualSmart
- Status last verified
- Nov 2026
- First submitted
- 23 Sep 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Arm With Performance Goal Study to Evaluate Safety and Effectiveness of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator in Persistent Atrial Fibrillation (PsAF)
- ClinicalTrials.gov ID
- NCT07845682
- Acronym / sponsor ID
- DualSmart / BWI202507
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2026 (actual)
- Primary completion
- 17 Apr 2028 (estimated)
- Study completion
- 17 Apr 2028 (estimated)
- First posted
- 29 Sep 2026 (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.
This purpose of this study is to understand how safe Biosense Webster Pulsed Field (PF)/Radiofrequency (RF) ablation system is and how well it works over 12 months in participants with persistent atrial fibrillation (PsAF; abnormal heart signals that cause irregular heartbeats).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency/Pulsed Field Ablation | Experimental | Device: Radiofrequency/Pulsed Field AblationParticipants with persistent atrial fibrillation (PsAF) will undergo catheter ablation using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter in combination with the TRUPULSE™ generator according to the study procedural workflow. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented symptomatic persistent atrial fibrillation (AF), which is defined as continuous AF that sustains beyond 7 days and less than 1 year and is documented by the following: Physician's note indicating continuous AF greater than or equal to (>=) 7 days but no more than 1 year; AND 1) Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart (electrograms cannot >12 months prior to enrollment) OR 2) At least 24-hour Holter/ telemetry strip within 12 months prior to enrollment showing continuous AF
- Failed at least one (1) antiarrhythmic drug (AAD) (Class I or Class III) as evidenced by recurrent symptomatic AF, intolerable to the AAD
- Age 18-80 years
- Willing and capable of providing consent
- Able and willing to comply with all pre-, post- and follow-up testing and requirement
Key exclusion criteria (30 listed)
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, etcetera)
- Documented severe dilatation of the left atrium (LA) (LAD >50 millimetre [mm]) antero-posterior diameter on imaging within 6 months prior to procedure
- Documented severely compromised left ventricular ejection fraction (LVEF) (LVEF less than [<] 40 percent [%]) by imaging within 6 months prior to procedure
- Severe mitral regurgitation or insufficiency, or the report claims: Regurgitant volume >=60 millilitre (mL)/beat, Regurgitant fraction >=50%, and/or effective regurgitant orifice area >=0.40 square centimetre (cm^2).
- Moderate-severe, severe tricuspid valve regurgitation or insufficiency
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 |
|---|---|---|
| Radiofrequency/Pulsed Field AblationRadiofrequency and pulsed field ablation by Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter with the TRUPULSE™ generator will be used. | Device | Radiofrequency/Pulsed Field Ablation |
Primary outcome
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
Time frame: Day 91 up to Day 365 post index procedure
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (that is, atrial fibrillation or atrial tachycardia or atrial flutter [AF, AT or AFL] of unknown origin) episodes based on electrocardiographic data and freedom from acute procedural failure, repeat ablation failure, non-study device failure, antiarrhythmic drug (AAD) failure, continuous AF/AT/AFL of unknown origin, and any direct current (DC) cardioversion procedure will be reported.
Occurrence of Early Onset Primary Adverse Event (PAE)
Time frame: Within 7 days post index procedure
PAEs include the following Adverse Events (AEs): esophageal perforating complications (Atrio-esophageal fistula occuring up to 90 days post ablation procedure); phrenic nerve paralysis; cardiac Tamponade, perforation (occuring up to 30 days post ablation procedure); pulmonary vein stenosis (anytime during the 12 month follow up period); device or procedure related death (anytime during or after the ablation procedure); stroke/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.
1 secondary outcome
Change From Baseline in Quality of life, As Measured by the Total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score at 12 Months Post Procedure
Time frame: Baseline, At 12 months post procedure
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 4 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/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
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
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Atrial Fibrillation (AF)
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.
Biosense Webster, Inc. Clinical Trial study director
Biosense Webster, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency/Pulsed Field Ablation in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 4 sites 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 5 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Contact Yun Bai (+86 15810492554, ybai8@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes (time frame: Day 91 up to Day 365 post index procedure). 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?
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 4 Nov 2026.