Status:
UNKNOWN
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
Lead Sponsor:
Adagio Medical
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
All Genders
18+ years
Phase:
NA
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,...
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05416086
Start Date
September 3 2021
End Date
December 30 2025
Last Update
October 10 2023
Active Locations (4)
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1
Onze-Lieve-Vrouw Hospital Aalst (OLV)
Aalst, Belgium, 9300
2
Universitatsklinikum Erlangen
Erlangen, Germany, 91054
3
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435
4
Erasmus MC
Rotterdam, Netherlands