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

Adagio Medical (Industry)
Overall Status
CT.gov ID

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: cryoablation procedure using the iCLAS Cryoablation System

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 Design

Study Type:
Anticipated Enrollment :
150 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
Actual Study Start Date :
Sep 3, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Primary outcome - freedom from AF [12 months]

    Freedom from Atrial Fibrillation (AF) recurrence during the 12-months follow-up period.

  2. Primary outcome - freedom from AF/AT/AFL [12 months]

    Freedom from Atrial Arrhythmia at 12-months

  3. 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

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)

Contacts and Locations


Site City State Country Postal Code
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

Sponsors and Collaborators

  • Adagio Medical


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Adagio Medical
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • CS-086
First Posted:
Jun 13, 2022
Last Update Posted:
Jun 13, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 13, 2022