Arrhythmias, CardiacDEVANCT07727057
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
A study testing Radiofrequency/Pulsed Field Ablation System in people with Arrhythmias, Cardiac, run by Biosense Webster, Inc. at 6 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- Radiofrequency/Pulsed Field Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 8 Jul 2026to 30 Sep 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is planned for a catheter ablation procedure to ablate either: (a) Premature ventricular complexes (PVCs); (b) Sustained monomorphic ventricular tachycardia (VT), including sustained monomorphic ischemic ventricular tachycardia (SMIVT) or sustained monomorphic non-ischemic ventricular tachycardia (SMNIVT), with one or more documented spontaneous episodes of symptomatic sustained monomorphic ventricular tachycardia within 3 months that required device therapy (shock or anti-tachycardia pacing), external cardioversion, escalated antiarrhythmic therapy, and/or hospitalization. Documented episodes will be assessed by review of electrocardiographic data.
- Age greater than or equal to 18 years
- Willing and capable of providing consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
- For participants with sustained monomorphic ventricular tachycardia (SMIVT or SMNIVT): participant must have an implantable cardioverter defibrillator (ICD) already implanted before the ventricular tachycardia ablation procedure, or implantation must be planned during or soon after the ablation procedure, during the same hospital admission
Who cannot join
- Incessant ventricular arrhythmia (VA) necessitating hemodynamic support prior to the ablation procedure
- Polymorphic ventricular tachycardia, unstable ventricular tachycardia, or ventricular fibrillation (VF)
- Idiopathic VTs
- Suspected reversible cause of VA (example, electrolyte abnormalities, thyroid disease, drug induced arrhythmia)
- VAs that are thought to be from channelopathies
- Severely compromised left ventricular ejection fraction (LVEF) (less than [<] 20 percentage [%])
Show all 27Show fewer
- Uncontrolled heart failure or New York Heart Association (NYHA) Class IV
- Pre-procedure stimulation protocol anticipated to be unsafe at the time of the screening visit (e.g., hemodynamically unstable participants, participants with ventricular fibrillation), per Site Investigator discretion
- Previous Percutaneous Coronary Intervention (PCI) / Myocardial Infarction (MI) within the past 2 months
- Unstable angina pectoris within the past 6 months.
- Presence of intracardiac thrombus on pre-ablation imaging
- Presence of a condition that precludes vascular access (such as inferior vena cava [IVC] filter in case of anterograde approach)
- Epicardial mapping or ablation already anticipated or planned at the time of the screening visit (that is, pre-planned epicardial approach before index VA ablation per protocol)
- History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
- Contraindication to contrast agents.
- Life expectancy < 6 months, including advanced heart failure or terminal illness (at the discretion of the Investigator)
- Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 6 months
- Previous VA ablation within 6 months
- 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 clinical investigation
- Significant congenital anomaly or medical problem that in the opinion of the principal Investigator would preclude enrollment in the study
- Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions For Use (IFU)
- Ventriculotomy or atriotomy within the preceding 8 weeks
- Presence of myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
- Prosthetic valves
- Acute illness, active systemic infection, or sepsis
- Current enrollment in an investigational study evaluating another device, biologic, or drug
- Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
Austria2 sites, 2 recruiting
- Recruiting
Medizinische Universitat Graz
Graz, 8036
- Recruiting
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020
Belgium2 sites, 2 recruiting
- Recruiting
AZORG campus Aalst Moorselbaan
Aalst, 9300
- Recruiting
AZ Sint-Jan Brugge
Bruges, 8000
Germany2 sites, 2 recruiting
- Recruiting
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale, 97616
- Recruiting
TUM Klinikum Deutsches Herzzentrum
München, 80636
About this study
Official title: Workflow Study of the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias (VAs)
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.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- Radiofrequency/Pulsed Field Ablation System
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency/Pulsed Field Ablation SystemDevice
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 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. Receives: Device: Radiofrequency/Pulsed Field Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 7 days post index ablation procedure
Secondary outcomes (23)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Intraoperative
Total Procedure Time
Total procedure time is defined as first femoral puncture to last catheter out.
Measured: 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.
Measured: Intraoperative
Mapping Time
Mapping time will be reported.
Measured: Intraoperative
Mapping Types
Types of mapping will be reported.
Measured: Intraoperative
Total Fluoroscopy Time
Total fluoroscopy time will be reported.
Measured: Intraoperative
Fluid Delivered From the Study Catheter
Total fluid delivered from the study catheter will be reported.
Measured: Intraoperative
Use of Paralytics
Use of paralytics will be reported.
Measured: Intraoperative
Type of Anesthesia
Type of anesthesia used will be reported.
Measured: Intraoperative
Number of Ablation Applications
Number of ablation applications will be reported.
Measured: Intraoperative
Number of Ablation Applications by Locations
Number of ablation applications by locations will be reported.
Measured: Intraoperative
Ablation Parameters: Temperature
Temperature during ablation per application and by location will be reported.
Measured: Intraoperative
Ablation Parameters: Power
Power applied during ablation per application and by location will be reported.
Measured: Intraoperative
Ablation Parameters: Impedance
Impedance recorded during ablation per application and by location will be reported.
Measured: Intraoperative
Ablation Parameters: Contact Force (CF)
Contact force applied during ablation per application and by location will be reported.
Measured: 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.
Measured: Intraoperative
Ablation Parameters: Radiofrequency (RF) Power
RF power applied during ablation per application and by location will be reported.
Measured: Intraoperative
Ablation Parameters: Application Time
Application time for ablation per application and by location will be reported.
Measured: Intraoperative
Ablation Parameters: Pulsed Field/Radiofrequency Tag Index per Location
PF/RF tag index recorded per anatomical location during ablation will be reported.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start8 Jul 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Medical Clinical Trial, Study director, Johnson & Johnson K.K. Medical Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727057
- Sponsor's protocol ID
- BWI202601
- Other IDs
- BWI202601
- Acronym
- DEVA
- Status last verified
- Nov 2026
- First submitted
- 2 Jul 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
- Workflow Study of the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias (VAs)
- ClinicalTrials.gov ID
- NCT07727057
- Acronym / sponsor ID
- DEVA / BWI202601
- Conditions
- Arrhythmias, Cardiac
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 27 Jul 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.
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.
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 Ablation SystemParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is planned for a catheter ablation procedure to ablate either: (a) Premature ventricular complexes (PVCs); (b) Sustained monomorphic ventricular tachycardia (VT), including sustained monomorphic ischemic ventricular tachycardia (SMIVT) or sustained monomorphic non-ischemic ventricular tachycardia (SMNIVT), with one or more documented spontaneous episodes of symptomatic sustained monomorphic ventricular tachycardia within 3 months that required device therapy (shock or anti-tachycardia pacing), external cardioversion, escalated antiarrhythmic therapy, and/or hospitalization. Documented episodes will be assessed by review of electrocardiographic data.
- Age greater than or equal to 18 years
- Willing and capable of providing consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
- For participants with sustained monomorphic ventricular tachycardia (SMIVT or SMNIVT): participant must have an implantable cardioverter defibrillator (ICD) already implanted before the ventricular tachycardia ablation procedure, or implantation must be planned during or soon after the ablation procedure, during the same hospital admission
Key exclusion criteria (27 listed)
- Incessant ventricular arrhythmia (VA) necessitating hemodynamic support prior to the ablation procedure
- Polymorphic ventricular tachycardia, unstable ventricular tachycardia, or ventricular fibrillation (VF)
- Idiopathic VTs
- Suspected reversible cause of VA (example, electrolyte abnormalities, thyroid disease, drug induced arrhythmia)
- VAs that are thought to be from channelopathies
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 Ablation SystemRadiofrequency 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
PVC Arm: Effectiveness of the Procedural Workflow
Time frame: At 3 Months post index ablation procedure
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.
SMIVT and SMNIVT arms: Effectiveness of the Procedural Workflow
Time frame: At 6 months post index ablation procedure
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.
Occurrence of Primary Adverse Events (PAE)
Time frame: Up to 7 days post index ablation procedure
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.
23 secondary outcomes
Occurrence of Serious Adverse Device Effects (SADEs)
Time frame: Up to Day 180 post index ablation procedure
Occurrence of Unanticipated Serious Adverse Device Effects (USADEs)
Time frame: Up to Day 180 post index ablation procedure
Occurrence of SAEs
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)
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
Time frame: Intraoperative
Total Procedure Time
Time frame: Intraoperative
Study Catheter Left Ventricle (LV) and/or Right Ventricle (RV) Dwell Time
Time frame: Intraoperative
Mapping Time
Time frame: Intraoperative
Mapping Types
Time frame: Intraoperative
Total Fluoroscopy Time
Time frame: Intraoperative
Fluid Delivered From the Study Catheter
Time frame: Intraoperative
Use of Paralytics
Time frame: Intraoperative
Type of Anesthesia
Time frame: Intraoperative
Number of Ablation Applications
Time frame: Intraoperative
Number of Ablation Applications by Locations
Time frame: Intraoperative
Ablation Parameters: Temperature
Time frame: Intraoperative
Ablation Parameters: Power
Time frame: Intraoperative
Ablation Parameters: Impedance
Time frame: Intraoperative
Ablation Parameters: Contact Force (CF)
Time frame: Intraoperative
Ablation Parameters: PF-only, RF-only, PF/RF, RF/PF Ablations Procedures
Time frame: Intraoperative
Ablation Parameters: Radiofrequency (RF) Power
Time frame: Intraoperative
Ablation Parameters: Application Time
Time frame: Intraoperative
Ablation Parameters: Pulsed Field/Radiofrequency Tag Index per Location
Time frame: Intraoperative
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
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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.
Johnson & Johnson Medical Clinical Trial study director
Johnson & Johnson K.K. Medical Company
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency/Pulsed Field Ablation System in people with Arrhythmias, Cardiac, run by Biosense Webster, Inc. at 6 sites in 3 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 27 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 6 sites in Austria, Belgium, Germany. 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 Katie Steenackers, MD (+32 2 746 39 14, KSteenac@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PVC Arm: Effectiveness of the Procedural Workflow (time frame: At 3 Months post index ablation procedure). The study lists 3 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.