iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study

Study Overview
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Brief Summary
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A prospective, single-arm, multi-center study designed to collect real world safety and performance data of the Adagio Medical iCLAS Cryoablation System in the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL).

Detailed Description
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This Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical iCLAS™ Cryoablation System in real world clinical settings.

Official Title
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iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study

Conditions
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Atrial Fibrillation, Atrial Flutter, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: cryoablation procedure using the iCLAS Cryoablation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 years of age Planned ablation procedure according to the indication for use of the commercially available Adagio iCLAS™ Cryoablation System Subject willing to comply with study requirements and give informed consent. Exclusion Criteria: In the opinion of the Investigator, any known contraindication to an atrial ablation procedure with the Adagio iCLAS™ Cryoablation System as indicated in the device Instructions For Use (IFU). Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor. Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than one year, extensive travel away from the research center)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: iCLAS Cryoablation arm<br>all subjects will receive a cryoablation procedure with the iCLAS System and be followed up for 12-month | Device: cryoablation procedure using the iCLAS Cryoablation System<br>* all subjects will receive a cryoablation procedure using the iCLAS Cryoablation System (catheter, stylets, and console) and warming balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome - freedom from AF | Freedom from Atrial Fibrillation (AF) recurrence during the 12-months follow-up period. | 12 months | 
| Primary outcome - freedom from AF/AT/AFL | Freedom from Atrial Arrhythmia at 12-months | 12 months | 
| Primary outcome - freedom from Device/Procedure Related Adverse Events | Freedom from Device / Procedure Related Adverse Events during and after the ablation procedure through12-month follow up | during procedure and up to 12-month follow up |