Abnormal heart rhythm Atrial Fibrillation
Conditions
Interventions
The Cryoablation System achieves its intended purpose by creating and
controlling the conditioning of Nitrogen to its critical point (CN2) within the
Cryoablation console and subsequently creating a
Sponsors
Adagio Medical Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient is diagnosed with Paroxysmal (PAF), Persistent (PsAF) or Long-Standing Persistent atrial fibrillation for which an ablation procedure was deemed most appropriate therapy: Paroxysmal AF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven (7) days. Persistent AF is defined as: an episode lasting longer than seven (7) days, but less than one (1) year documented by consecutive ECG recordings of 100% AF greater than seven (7) days apart or an episode requiring electrical or pharmacological cardioversion after 48 hours of AF documented by continuous recording. Long-Standing Persistent AF is defined as continuous AF that lasts longer than one (1) year. 2. Reported incidence of at least one (1) documented episode of symptomatic AF during the twelve (12) months preceding trial entry (should be documented by rhythm strip or ECG). 3. Failure of at least one (1AAD for AF [class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic AF, or intolerable side effects due to AAD.
Exclusion criteria
Exclusion criteria: 1. Patient had any previous left atrial ablation. 2. History of any valvular cardiac surgical procedure, atrial septal defect closure device; or left atrial appendage closure device. 3. Coronary artery bypass grafting (CABG) procedure within the last 3 months. 4. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months. 5. Atrial clot/thrombus on imaging such as on a trans-esophageal echocardiogram (TEE) performed within 48 hours of the procedure if deemed appropriate by the investigator. 6. History of a documented thromboembolic event within the past one (1) year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: The primary safety endpoint will be determined by evaluating: • the incidence of procedural adverse events • the incidence of serious adverse events within 7 days of procedure, > 7 days, and > 30 days Performance: Technical performance assessed by: • complete electrical isolation of all pulmonary veins (entrance block) • AF termination targeting driver regions, when applicable • complete linear block of linear lesions if deployed | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance: performance assessed by: • percentage of RF focal ablation (touch up) to reach the primary performance endpoint • procedural parameters (fluoro, ablation and total procedural times) • complete freedom from documented AF or other atrial tachycardia (> 30 s), using 48-hour Holter monitor at 12 months post ablation, after a single procedure and off AAD (Anti Arrhythmic Drug) (includes a three month blanking period). | — |
Countries
Netherlands
Outcome results
None listed