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| ID | Type | Description | Link |
|---|---|---|---|
| BWI202525 | Other Identifier | Biosense Webster, Inc. |
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The main purpose of this study is to investigate the workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE catheter and TRUPULSE generator) when used for cardiac ablation with the new VARIPULSE Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days, often resolving within 24-48 hours, though sometimes lasting up to a week) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Field Ablation: VARIPULSE Catheter with TRUPULSE Generator and VARIPULSE Pro Software | Experimental | Participants undergoing cardiac ablation for management of treatment of symptomatic Persistent Atrial Fibrillation (PsAF) or Paroxysmal Atrial Fibrillation (PAF) will undergo pulsed field ablation (PFA) with the VARIPULSE Catheter and the TRUPULSE Generator with the new VARIPULSE Pro software. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Field Ablation System | Device | Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator along with VARIPULSE pro software will be used. |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Procedure Time | The total procedure time will be reported. | Intraoperative |
| Pulsed Field (PF) Application Time | The PF application time will be reported. | Intraoperative |
| Number of PF applications by Pulmonary Vein (PV) | Number of PF applications by PV will be reported. | Intraoperative |
| Number of PF applications by Other Cardiac Locations | Number of PF applications by other cardiac locations will be reported. | Intraoperative |
| Number of PF applications by Participant | Number of PF applications by participant will be reported. | Intraoperative |
| Pulmonary Vein Isolation (PVI) Time | Time to PVI will be reported. | Intraoperative |
| Total Fluoroscopy Time | The total time that fluoroscopy/ X-Ray system used during the ablation procedure will be reported. | Intraoperative |
| Total Study Catheter Left Atrial Dwell Time | The total study catheter left atrial dwell time (that is time between the ablation catheter entering the left atrium to its withdrawal from the left atrium) will be reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Serious Adverse Device Effects (SADE; Within Seven [7] Days of Index Ablation Procedure) Where the Investigational Devices were Used per Clinical Investigation Plan | A SADE is an adverse device effect that has resulted in any of the consequences characteristic of an 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie Macours | Contact | +32 2 746 30 76 | nmacours1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Biosense Webster, Inc. Clinical Trial | Biosense Webster, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZORG campus Aalst Moorselbaan | Not yet recruiting | Aalst | 9300 | Belgium | ||
| A.Z. Sint Jan |
The data sharing policy of Johnson & Johnson MedTech is available at www.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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| Intraoperative |
| Acute Effectiveness | Acute procedural success, which is defined as electrical isolation of clinically relevant targeted PVs (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure will be reported. | Intraoperative |
| Up to 7 days 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. | Up to 3 months 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. | At 7 days, 8 to 30 days (peri-procedural) and Up to 3 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. | Up to 3 months post index ablation procedure |
| Number of Participants with PVI Durability | PVI durability is defined as a sustained isolations of PVs that are targeted in the index ablation procedure, which is evidenced by the confirmation of isolation via the electro-anatomical mapping 90 days (+/- 14 days) post index ablation procedure. | Up to 90 days post index ablation procedure |
| Not yet recruiting |
| Bruges |
| 8000 |
| Belgium |
| Aarhus University Hospital | Not yet recruiting | Aarhus N | 8200 | Denmark |
| Hospices Civils de Lyon HCL | Not yet recruiting | Bron | 69500 | France |
| Institut Medico chirurgical Montsouris | Not yet recruiting | Paris | 75014 | France |
| University Hospital of the Ruhr-University of Bochum | Not yet recruiting | Bad Oeynhausen | 32545 | Germany |
| Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata' | Not yet recruiting | Roma | 00133 | Italy |
| IRCCS Policlinico San Donato | Not yet recruiting | San Donato Milanese | 20097 | Italy |
| Vilnius University Hospital Santaros Clinics | Recruiting | Vilnius | 08406 | Lithuania |
| Erasmus MC | Not yet recruiting | Rotterdam | 3015 | Netherlands |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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