Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI. All subjects will be followed for twelve (12) months after completion of the index ablation procedure.
A multi-center, open-label, prospective, single-arm, pre-market clinical study. Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI. All subjects will be followed for twelve (12) months after completion of the index ablation procedure. Data will be collected at enrollment, procedure, discharge, 1, 3, 6 and 12- months to assess the safety and effectiveness of the System. Testing for recurrence of atrial fibrillation will include a 12-lead ECG at 1, 3, 6 and 12-months post-ablation, weekly event recorder transmissions (TTM) after the 3-month follow-up visit through the 12-month follow up, and a 24-h continuous Holter ECG recording at 6 and 12-months post ablation. Symptom triggered rhythm monitoring will be used throughout the effectiveness post-ablation period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
128
The Synaptic Cryo Balloon must be used to isolate all targeted pulmonary veins. Entrance block will be confirmed in all targeted pulmonary veins (PVs) after a 20-minute waiting period or provocative testing with adenosine or isoproterenol. Any additional ablation in the LA beside PV isolation is not allowed in this protocol. Additional ablation of the cavo-tricuspid isthmus (CTI) with a conventional market-approved RF catheter is allowed only in case a typical atrial flutter is documented in prior patient history or occurs during the case (either spontaneously or inducible).
Banner University Medical Center
Phoenix, Arizona, United States
Dignity Health Arizona Research Enterprise
Phoenix, Arizona, United States
St. Bernard's Heart & Vascular
Jonesboro, Arkansas, United States
safety - proportion of subjects who experienced device/procedure related Major Adverse Events (MAEs)
The primary endpoint for safety is an analysis of the proportion of subjects who experienced device/procedure related Major Adverse Events (MAEs) that occur during the procedure or through the 6-month follow-up of the study. MAEs include any of the major complications as defined in the 2017 HRS expert consensus statement
Time frame: 6 months
Effectiveness
The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data through 12-month follow-up and excluding a 90- day blanking period.
Time frame: 12 months
Safety - Incidence of early onset (within 7 days of the index ablation procedure) of serious adverse events (SAEs)
Incidence of early onset (within 7 days of the index ablation procedure) of serious adverse events (SAEs)
Time frame: 7 days
Safety - Incidence of late onset (>7 days) of SAEs
Incidence of late onset (\>7 days) of SAEs
Time frame: 12 months
Safety - Change from baseline NIH Stroke Scale post-ablation
Change from baseline NIH Stroke Scale post-ablation
Time frame: Day 1
Effectiveness - Rate of acute procedural success, defined as confirmation of entrance block in all targeted pulmonary veins
Rate of acute procedural success, defined as confirmation of entrance block in all targeted pulmonary veins
Time frame: Day 0
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Mercy General Hospital
Sacramento, California, United States
St. Luke's Mid America
Kansas City, Missouri, United States
Northwell Health - Lenox Hill Hospital
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Christus Health Frances Hospital
Tyler, Texas, United States
VCU Pauley Heart Center
Richmond, Virginia, United States
Effectiveness - Rate of pulmonary vein isolation on a per-vein basis
• Rate of pulmonary vein isolation on a per-vein basis
Time frame: Day 0
Effectiveness - Use of antiarrhythmic drugs (AADs) during the effectiveness evaluation period
Use of antiarrhythmic drugs (AADs) during the effectiveness evaluation period
Time frame: 12 months
Effectiveness - Freedom from documented symptomatic AF or new onset of AFL/AT through 12-month follow-up and excluding the 90- day blanking period
Freedom from documented symptomatic AF or new onset of AFL/AT through 12-month follow-up and excluding the 90- day blanking period
Time frame: 12 months
Effectiveness - Freedom from documented symptomatic AF or new onset of AFL/AT off antiarrhythmic drug therapy through 12-month follow-up and excluding the 90-day blanking period
Freedom from documented symptomatic AF or new onset of AFL/AT off antiarrhythmic drug therapy through 12-month follow-up and excluding the 90-day blanking period
Time frame: 12 months
Effectiveness - Failure-free rate as defined in primary effectiveness endpoint at 6 months post procedure
Failure-free rate as defined in primary effectiveness endpoint at 6 months post procedure
Time frame: 6 months
Performance - Single procedure success defined as freedom from primary effectiveness failure without a repeat procedure
Single procedure success defined as freedom from primary effectiveness failure without a repeat procedure
Time frame: 12 months
Performance - Procedure time, defined as the time elapsed from first venous access to last sheath removal
Procedure time, defined as the time elapsed from first venous access to last sheath removal
Time frame: Day 0
Performance - Duration of LA dwell time, defined as time from the Cryo Balloon Catheter exiting the sheath in the LA to time of final PVI
Duration of LA dwell time, defined as time from the Cryo Balloon Catheter exiting the sheath in the LA to time of final PVI
Time frame: Day 0
Performance - Total cryoablation time for index procedure
Total cryoablation time for index procedure
Time frame: Day 0
Performance - Total fluoroscopy time for index procedure
Total fluoroscopy time for index procedure
Time frame: Day 0
Performance - Treatment time, defined as the time from the start of the first ablation delivery to the end of the last ablation delivery
Treatment time, defined as the time from the start of the first ablation delivery to the end of the last ablation delivery
Time frame: Day 0
Performance -Changes in the quality-of-life measures (AFEQT) between baseline and 12-month follow-up
Changes in the quality-of-life measures (AFEQT) between baseline and 12-month follow-up
Time frame: 12 months