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

Not Applicable

Recruiting

• Conditions: Persistent Atrial Fibrillation; Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Atrial Flutter
• Interventions: Device: cryoablation procedure using the iCLAS Cryoablation System

• Registration Number: NCT05416086
• Lead Sponsor: Adagio Medical

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.

Study Timeline

• Study Start: 2021-09-03
• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-13
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iCLAS Cryoablation arm	cryoablation procedure using the iCLAS Cryoablation System	all subjects will receive a cryoablation procedure with the iCLAS System and be followed up for 12-month

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (4)

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Universitatsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Onze-Lieve-Vrouw Hospital Aalst (OLV); 🇧🇪 Aalst, Belgium

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands