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TERMINATED
NCT05416086
NA

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

Sponsor: Adagio Medical

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

91

Start Date

2021-09-03

Completion Date

2025-01-28

Last Updated

2026-04-13

Healthy Volunteers

Yes

Interventions

DEVICE

cryoablation 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

Locations (4)

Onze-Lieve-Vrouw Hospital Aalst (OLV)

Aalst, Belgium

Universitatsklinikum Erlangen

Erlangen, Germany

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Erasmus MC

Rotterdam, Netherlands