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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator along with VARIPULSE pro software will be used.
AZORG campus Aalst Moorselbaan
Aalst, Belgium
NOT_YET_RECRUITINGA.Z. Sint Jan
Bruges, Belgium
NOT_YET_RECRUITINGAarhus University Hospital
Aarhus N, Denmark
NOT_YET_RECRUITINGHospices Civils de Lyon HCL
Bron, France
NOT_YET_RECRUITINGInstitut Medico chirurgical Montsouris
Paris, France
NOT_YET_RECRUITINGUniversity Hospital of the Ruhr-University of Bochum
Bad Oeynhausen, Germany
NOT_YET_RECRUITINGAzienda Ospedaliera Universitaria 'Policlinico Tor Vergata'
Roma, Italy
NOT_YET_RECRUITINGIRCCS Policlinico San Donato
San Donato Milanese, Italy
NOT_YET_RECRUITINGVilnius University Hospital Santaros Clinics
Vilnius, Lithuania
RECRUITINGErasmus MC
Rotterdam, Netherlands
NOT_YET_RECRUITINGTotal Procedure Time
The total procedure time will be reported.
Time frame: Intraoperative
Pulsed Field (PF) Application Time
The PF application time will be reported.
Time frame: Intraoperative
Number of PF applications by Pulmonary Vein (PV)
Number of PF applications by PV will be reported.
Time frame: Intraoperative
Number of PF applications by Other Cardiac Locations
Number of PF applications by other cardiac locations will be reported.
Time frame: Intraoperative
Number of PF applications by Participant
Number of PF applications by participant will be reported.
Time frame: Intraoperative
Pulmonary Vein Isolation (PVI) Time
Time to PVI will be reported.
Time frame: Intraoperative
Total Fluoroscopy Time
The total time that fluoroscopy/ X-Ray system used during the ablation procedure will be reported.
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: Up to 90 days post index ablation procedure