This study aims to evaluate the safety of the Adagio AF Cryoablation System (iCLAS™) for ablation treatment of persistent atrial fibrillation. Data collected as a result of the study will be used for a pre-market application. Patients will complete an ablation procedure with the iCLAS™ device. Follow-up appointments will take place after 1, 3, 6, and 12 months.
200 subjects will be enrolled in the study. The primary purpose of the trial is treatment. The study began on December 9, 2019 and is estimated to be completed by December 9, 2021.
- Male or female between the ages of 18 – 80 years
- Currently scheduled for an ablation of symptomatic PsAF defined as continuous AF that is sustained > 7-days and ≤ 12-months.
- Refractory to at least one class I or III AAD.
- Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
- Willingness and ability to give an informed consent
- Any duration of continuous AF lasting longer than 12-months
- History of previous left atrial ablation or surgical treatment for AF/AFL/AT
- Atrial fibrillation secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
- Significant structural heart disease
- BMI > 35
- Any prior history of documented cerebral infarct or systemic embolism (excluding a post-operative DVT)
- Any prior history or current evidence of hemidiaphragmatic paralysis
- Pregnant or lactating (current or anticipated during study follow-up
- Vulnerable patient
This study will take place at The Valley Hospital, Ridgewood, New Jersey, United States, 07450. If you have any questions, please contact Sarah Polites, BSN, RN, CCCRN-K at 201-447-8453.
Sponsors / Collaborators
This study is sponsored by Adagio Medical. The principal investigator is Suneet Mittal, MD.
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