Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BWI202513 | Other Identifier | Biosense Webster, Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 persistent atrial fibrillation (PsAF; irregular, rapid heart rhythm that lasts over 7 days and doesn't stop on its own)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) will undergo pulsed field ablation (PFA) with the VARIPULSE Catheter and the TRUPULSE Generator with the new VARIPULSE Pro software. |
|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Procedural Success | 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 |
| Pulmonary Vein Isolation (PVI) Durability | PVI durability is defined as sustained isolation 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 3 months post index ablation procedure |
| Pulsed Field (PF) Applications Time | PF applications time will be reported. | Intraoperative |
| Number of PF applications | Number of PF applications will be reported. | Intraoperative |
| Tissue Proximity Indication (TPI) | TPI will be reported. | Intraoperative |
| 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. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wannes Vermander | Contact | +32 494 03 08 40 | wverman1@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 | Recruiting | Aalst | 9300 | Belgium | ||
| A.Z. Sint Jan |
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 ife-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 |
| Occurrence of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by Magnetic Resonance Imaging (MRI) Evaluations | Occurrence of new post-ablation asymptomatic and symptomatic cerebral emboli will be evaluated using cerebral MRI performed post-ablation. | Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure |
| Anatomical Location of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by MRI Evaluations | Anatomical location of new post-ablation asymptomatic and symptomatic cerebral emboli will be evaluated using cerebral MRI performed post-ablation. | Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure |
| Size of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by Magnetic Resonance Imaging (MRI) Evaluations | Size of new post-ablation asymptomatic and symptomatic cerebral emboli will be evaluated using cerebral MRI performed post-ablation. | Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure |
| Occurrence of New or Worsening Neurological Deficits | Occurrence of new or worsening neurological deficits will be assessed. | Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure |
| Mini Mental State Examination (MMSE) Total Score | The MMSE is a, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment. | Baseline (within 72 hours prior to ablation), and post-ablation (72 hours after ablation procedure) |
| National Institutes of Health Stroke Scale (NIHSS) Score | The NIHSS is a clinician-reported measure of neurological deficit with scores ranging from 0 to 42. No stroke symptoms (0), mild stroke (1-4), moderate stroke (5-15), moderate to severe stroke (16-20), and sever (21-42). | Baseline (within 72 hours pre ablation procedure), and post-ablation (72 hours after ablation procedure) |
| Modified Rankin Scale (mRS) Scale Score | The mRS score is a validated score measuring neurologic outcomes after cardio-pulmonary resuscitation (CPR) where:
| Baseline (within 72 hours pre ablation procedure), and post-ablation (72 hours after ablation procedure) |
| Occurrence of Severe Pulmonary Vein (PV) Stenosis | Occurrence of severe PV stenosis as determined by Computed Tomography (CT)/ Magnetic Resonance Angiogram (MRA) evaluations will be reported. | Up to 3 months post index ablation procedure |
| Recruiting |
| Bruges |
| 8000 |
| Belgium |
| Aarhus University Hospital | 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 |
Not provided
Not provided