The primary purpose of this study is to assess the effectiveness of using CARTOFINDER™ maps created by the RHYTHMFINDER-192 catheter and the CARTOFINDER™ Algorithm to terminate persistent atrial fibrillation (PsAF) to either Normal Sinus Rhythm or Atrial Tachycardia compared to pulmonary vein isolation (PVI) in treating PsAF. The RHYTHMFINDER-192 catheter is investigational, while the CARTOFINDER™ system is CE marked in Europe. All subjects with persistent AF who are scheduled to undergo a clinically indicated ablation procedure for management of their persistent AF will be the target population for screening. The study will enroll approximately 40-70 subjects. Subjects will undergo CARTOFINDER™ guided ablation (CFGA) followed by PVI. Subjects will have follow-up visits at 7 days, 3, 6 and 12 months postprocedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
cartofinder guided ablation followed by PVI
OLV Aalst
Aalst, Belgium
AZ Sint-Jan Brugge
Bruges, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Nemocnice České Budějovice
České Budějovice, Czechia
St Bartholomew's hospital
London, United Kingdom
London Health Sciences Center
London, United Kingdom
Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) Only (Before Pulmonary Vein Isolation [PVI] and Without Cardioversion).
Acute success defined as rate of conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia, after CARTOFINDER Guided Ablation (CFGA) only (before Pulmonary Vein Isolation \[PVI\] and without cardioversion).
Time frame: Up to 7 days
Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) and Pulmonary Vein Isolation (PVI) Without Cardioversion
Acute success defined as rate of conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia, after CFGA and PVI without Cardioversion.
Time frame: Up to 7 days
Percentage of Participants With Procedural Success
Procedural success defined as the conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia after overall ablation procedure, with or without the need for cardioversion.
Time frame: Up to 7 days
Percentage of Participants With Recurrence of Atrial Fibrillation, Atrial Flutter, and Atrial Tachycardia Episodes of Greater Than or Equal to (>=) 30 Seconds to Measure the Effectiveness Success Rate for up to 12 Months
Documented AF/AT/AFL recurrence is defined as any occurrence of documented (symptomatic) atrial fibrillation, atrial flutter, and atrial tachycardia episodes \>= 30 seconds during the post-blanking period (Day 91-365). Here 'HM' signifies Holter monitoring.
Time frame: Up to 12 months
Number of Participants With Early-onset Primary Adverse Events
Incidence of early-onset (within 7 days of the initial mapping and ablation procedure) Primary Adverse Events (PAEs) was reported. PAEs included death, Atria-Esophageal Fistula, Cardiac Tamponade/Perforation, Myocardial Infarction, Stroke/Cerebrovascular Accident, Thromboembolism, Transient Ischemic Attack, Diaphragmatic Paralysis, Pneumothorax, Heart Block, Pulmonary Vein Stenosis, Pulmonary Edema (Respiratory Insufficiency), Pericarditis and Major Vascular Access Complication/Bleeding.
Time frame: Up to 7 days
Number of Participants With Confirmed Entrance Block After Adenosine/Isoproterenol Challenge
Number of participants with confirmed entrance block after adenosine/isoproterenol challenge was reported.
Time frame: Up to 12 months
Change of Intra-cycle Length From Pre-CFGA (Baseline) to Post-CFGA and Post-PVI
Change of intra-cycle length from pre-CFGA to post-CFGA and post-PVI is reported to measure the slowing for the overall Atrial Fibrillation rate in both atrium's.
Time frame: Pre-CFGA (Baseline) to Post-CFGA and Post-PVI (Up to 7 days)
Number of Participants With Serious Adverse Device Effects (SADEs) up to 12 Months
Any serious adverse event which was related to the device and/or the procedure was defined as a SADE.
Time frame: Up to 12 months
Number of Participants With All Serious Adverse Events (SAEs) up to 12 Months
Number of participants with SAEs will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to 12 months
Number of Participants With Adverse Device Effects (ADEs) up to 12 Months
Number of participants with adverse device effects was reported. Adverse Device Effect (ADE's) are adverse events related to the use of an investigational medical device. This definition includes adverse events resulting from insufficient or inadequate instructions for use deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. This definition includes any event resulting from use errors or from intentional misuse of the investigational medical device.
Time frame: Up to 12 months
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Number of Participants With Procedural Related Serious Adverse Event and Non-serious Adverse Events
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with treatment and therefore can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal product, whether or not related to that medicinal product. TEAEs were defined as AEs that were reported or worsened on after start of study drug(s) dosing through safety follow-up visit. A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time frame: Up to 12 months