A prospective, two-arm, multi-center, randomized, open-label, pre-market, First-in-Human clinical study designed to provide safety and performance data regarding the use of the Adagio PFA and PFCA Systems in the treatment of PsAF.
Enrolled subjects will be treated (ablation) with the Adagio PFA or PFCA System in a 1:1 randomized fashion. Treatment will include the isolation of pulmonary veins (PVIs), and isolation of the left atrial posterior wall (PWI), and CTI at the discretion and clinical judgment of the investigator. Data will be collected throughout 12-month follow up period to assess safety and performance of the device. Recurrence of atrial arrhythmias is measured by 12-lead ECGs and 48-hour continuous ECG recording (Holter).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Treatment will include the isolation of pulmonary veins (PVIs), and isolation of the left atrial posterior wall (PWI). A right atrial cavo-tricuspid line for bi-directional block may be performed at discretion and clinical judgment of the investigator
Onze-Lieve-Vrouwziekenhuis (OLV)
Aalst, Belgium
McGill University Health Centre (MUHC), Montreal General Hospital (MGH)
Montreal, Quebec, Canada
Nemocnice Na Homolce
Prague, Czechia
Blackrock Health
Dublin, Ireland
Primary Endpoint for Safety
Analysis of the proportion of subjects who are free from device/procedure-related Major Adverse Events that occur during or following the ablation procedure
Time frame: Up to 7 days following the ablation procedure
Primary Procedural Performance Outcome
Analysis of the evidence of procedural electrical isolation of all pulmonary veins, posterior wall, and bidirectional block (if applicable) across all other ablation lines using the study device.
Time frame: Procedure
One-Year Safety
Recording and analysis of all identified serious adverse events and serious adverse device effects through 12 months post-procedure.
Time frame: 12 months
One-Year Performance
Proportion of subjects receiving a single ablation procedure who has freedom from any documented left atrial arrhythmia (AF/AFL/AT) lasting longer than 30 seconds following the Blanking Period (3-months ± 14-days post index ablation) using a continuous 48-hour ECG recording through 12 months post-procedure.
Time frame: 12 months
Procedural Performance - ablation time
Ablation time defined as the total time for energy delivery to achieve PVI, PWI, and CTI (if applicable)
Time frame: procedure
Procedural Performance - procedure time
Total procedure time defined as the time from first venous access to the removal of the catheters from the heart at the end of the procedure
Time frame: procedure
Procedural Performance - fluoroscopy time
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St Antonius Ziekenhuis
Nieuwegein, Netherlands
St George'S University Hospital
London, United Kingdom
Procedure fluoroscopy time
Time frame: procedure
Procedural Performance - intraprocedural PV reconnection rate
The rate of intraprocedural PV reconnection - defined as confirmed conduction across a PVI line during the 20-minute waiting period to confirm PVI
Time frame: procedure
Procedural Performance - AAD use
Recording of the use of AADs in the follow up period beyond a 90-day blanking period
Time frame: procedure and up to 12-month
Procedural Performance - repeat ablation
Number of repeat ablations within and following the blanking period
Time frame: procedure and up to 12-month