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

April 8, 2026 updated by: Adagio Medical
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Onze-Lieve-Vrouw Hospital Aalst (OLV)
  • Germany
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen
  • Netherlands
      • Nieuwegein, Netherlands, 3435
        • St. Antonius Ziekenhuis
      • Rotterdam, Netherlands
        • Erasmus MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: iCLAS Cryoablation arm
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
all subjects will receive a cryoablation procedure using the iCLAS Cryoablation System (catheter, stylets, and console) and warming balloon

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adagio Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2021

Primary Completion (Actual)

January 28, 2025

Study Completion (Actual)

January 28, 2025

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 9, 2022

First Posted (Actual)

June 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on cryoablation procedure using the iCLAS Cryoablation System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe