An interventional study of Radiofrequency/Pulsed Field Ablation System in Arrhythmias, Cardiac, sponsored by Biosense Webster, Inc.. Recruiting at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Biosense Webster, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
Among 11 studies in Arrhythmias, Cardiac by Biosense Webster, Inc. — 2 open to participants now, 2 under way, none of them phase 3. Arrhythmias, Cardiac · Biosense Webster, Inc..
Among the 11 studies in Arrhythmias, Cardiac by Biosense Webster, Inc., this one is the 5th largest by planned enrollment of the 10 interventional ones, is the only one that started in 2026, is one of 2 with no phase, and was the 11th registered.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's planned enrollment of 90 is close to the median of 100 across 517 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →2 of the 11 studies in Arrhythmias, Cardiac by Biosense Webster, Inc. are open now, in 12 countries. Each count lists the studies.
Of the 167 Arrhythmias, Cardiac studies recruiting now, 118 (71%) set no upper age limit and 13 (8%) stop at 75 or younger; 31 take children under 18; 26 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2026.
Median enrollment 80 across the 10 interventional studies, 8,000 across the 1 observational. Of the 8 that completed or were terminated, 5 (63%) have results posted.
Biosense Webster, Inc. is the lead sponsor of 64 studies on the registry; 8 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 24 (92%) have results posted.
1 of the studies in Arrhythmias, Cardiac by Biosense Webster, Inc. that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07727057Biosense Webster, Inc.A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias | 2027-09-30 |
Among the 11 studies in Arrhythmias, Cardiac by Biosense Webster, Inc., from their registry updates:
Nothing recorded among them since 2026-09-25.
The purpose of this study is to collect information about how safe Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter with TRUPULSE™ Generator is and how effective a specific procedural workflow is when this ablation system is used to treat ventricular arrhythmias. The main aims of this study are to see whether the abnormal heart rhythm can be successfully treated while maintaining a specific procedural workflow with the catheter and generator during the cardiac ablation and to monitor participant safety after the procedure by checking if the participant has any complications.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergoing catheter ablation for the management of premature ventricular complexes (PVC), sustained monomorphic ischemic ventricular tachycardia (SMIVT) and sustained monomorphic non-ischemic ventricular tachycardia (SMNIVT) will undergo catheter ablation using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter in combination with the TRUPULSE™ generator, with radiofrequency and pulsed field energy delivered primarily as radiofrequency (RF)/pulsed field (PF) stacking applications according to the study procedural workflow.
Device: Radiofrequency/Pulsed Field Ablation System
Radiofrequency and pulsed field ablation by Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter with the TRUPULSE™ generator will be used.
PVC Arm: Effectiveness of the Procedural Workflow
Effectiveness of the procedural workflow for PVC arm is defined as reduction in burden at 3 months after the index ablation procedure compared to the baseline burden. PVC burden is defined as the percentage of PVCs relative to the total heartbeats measured during a 24-hour Holter monitoring.
Time frame: At 3 Months post index ablation procedure
SMIVT and SMNIVT arms: Effectiveness of the Procedural Workflow
Effectiveness of the procedural workflow for SMIVT and SMNIVT arm is defined as freedom from documented recurrence (symptomatic or asymptomatic) of any monomorphic VT based on electrocardiographic data (Holter or \>= 30 seconds on ECG or any appropriate ICD therapy) throughout 6 months after the index ablation procedure.
Time frame: At 6 months post index ablation procedure
Occurrence of Primary Adverse Events (PAE)
Occurrence of PAEs within 7 days of the index ablation procedure where the DE STSF Catheter and TRUPULSE Generator are used will be reported. PAEs include the following adverse events: cardiac tamponade/perforation, phrenic nerve paralysis (permanent), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction (MI), transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), vagal nerve injury/gastroparesis, aggravation or new onset heart failure, coronary artery injury, aortic dissection, and valve injury.
Time frame: Up to 7 days post index ablation procedure
Occurrence of Serious Adverse Device Effects (SADEs)
A SADE is an adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event (SAE). A SAE is any event that led to any of the following: Death, Serious deterioration in the health of a participant that resulted in any of the following: life-threatening illness or injury, permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of patient hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function, chronic disease and fetal distress, fetal death or a congenital physical or mental impairment or birth defect.
Time frame: Up to Day 180 post index ablation procedure
Occurrence of Unanticipated Serious Adverse Device Effects (USADEs)
An USADE is any SAE on health, safety, any life-threatening problem, or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, outcome, or degree of incidence in the current investigational plan or risk analysis report, or any other unanticipated serious problem associated with a device that relates to rights, safety, or welfare of participants.
Time frame: Up to Day 180 post index ablation procedure
Occurrence of SAEs
An SAE is any event that led to any of the following: Death, Serious deterioration in the health of a participant that resulted in any of the following: life-threatening illness or injury, permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of patient hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function, chronic disease and fetal distress, fetal death or a congenital physical or mental impairment or birth defect.
Time frame: Within 7 days (early-onset), 8 to 30 days and >30 days (late onset) that is up to 6 months post index ablation procedure
Occurrence of Non-Serious Adverse Events (Non-SAEs)
An Adverse Event (AE) means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in participants, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
Time frame: Within 7 days (early-onset), 8 to 30 days and >30 days (late onset) that is up to 6 months post index ablation procedure
Acute Effectiveness
Acute effectiveness (acute success) of the index VA ablation procedure performed using the DE STSF catheter in combination with the TRUPULSE Generator will be reported. It is defined as: * PVC arm: Acute success is defined as elimination of the targeted PVC(s) after awaiting period of at least 15 minutes, at the end of the procedure. * SMIVT and SMNIVT arms: Acute success is defined as elimination and non-inducibility of any monomorphic VT at the end of procedure.
Time frame: Intraoperative
Total Procedure Time
Total procedure time is defined as first femoral puncture to last catheter out.
Time frame: Intraoperative
Study Catheter Left Ventricle (LV) and/or Right Ventricle (RV) Dwell Time
Study catheter left ventricle (LV) and/or right ventricle (RV) dwell time during mapping and ablation will be reported.
Time frame: Intraoperative
Mapping Time
Mapping time will be reported.
Time frame: Intraoperative
Mapping Types
Types of mapping will be reported.
Time frame: Intraoperative
Total Fluoroscopy Time
Total fluoroscopy time will be reported.
Time frame: Intraoperative
Fluid Delivered From the Study Catheter
Total fluid delivered from the study catheter will be reported.
Time frame: Intraoperative
Use of Paralytics
Use of paralytics will be reported.
Time frame: Intraoperative
Type of Anesthesia
Type of anesthesia used will be reported.
Time frame: Intraoperative
Number of Ablation Applications
Number of ablation applications will be reported.
Time frame: Intraoperative
Number of Ablation Applications by Locations
Number of ablation applications by locations will be reported.
Time frame: Intraoperative
Ablation Parameters: Temperature
Temperature during ablation per application and by location will be reported.
Time frame: Intraoperative
Ablation Parameters: Power
Power applied during ablation per application and by location will be reported.
Time frame: Intraoperative
Ablation Parameters: Impedance
Impedance recorded during ablation per application and by location will be reported.
Time frame: Intraoperative
Ablation Parameters: Contact Force (CF)
Contact force applied during ablation per application and by location will be reported.
Time frame: Intraoperative
Ablation Parameters: PF-only, RF-only, PF/RF, RF/PF Ablations Procedures
Participants with PF-only, RF-only, PF/RF, RF/PF ablations per application and by location will be reported.
Time frame: Intraoperative
Ablation Parameters: Radiofrequency (RF) Power
RF power applied during ablation per application and by location will be reported.
Time frame: Intraoperative
Ablation Parameters: Application Time
Application time for ablation per application and by location will be reported.
Time frame: Intraoperative
Ablation Parameters: Pulsed Field/Radiofrequency Tag Index per Location
PF/RF tag index recorded per anatomical location during ablation will be reported.
Time frame: Intraoperative
Plan to share: 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
Data sharing details ↗ · www.jnj.com
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Sep 2027, 14 months after the start.
Of 71 industry-sponsored interventional studies with no phase under Arrhythmias, Cardiac, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's planned 14 months is close to that.
Counting every sponsor, half of 242 studies reached it within 24 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.