Atrial Fibrillation, Atrial Flutter, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
Brief summary
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
This Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical iCLAS™ Cryoablation System in real world clinical settings.
Interventions
DEVICEcryoablation procedure using the iCLAS Cryoablation System
all subjects will receive a cryoablation procedure using the iCLAS Cryoablation System (catheter, stylets, and console) and warming balloon
Sponsors
Adagio Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome - freedom from AF | 12 months | Freedom from Atrial Fibrillation (AF) recurrence during the 12-months follow-up period. |
| Primary outcome - freedom from AF/AT/AFL | 12 months | Freedom from Atrial Arrhythmia at 12-months |
| Primary outcome - freedom from Device/Procedure Related Adverse Events | during procedure and up to 12-month follow up | Freedom from Device / Procedure Related Adverse Events during and after the ablation procedure through12-month follow up |
Countries
Belgium, Germany, Netherlands
Outcome results
None listed