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

Last updated: October 6, 2023
Sponsor: Adagio Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atrial Fibrillation

Chest Pain

Arrhythmia

Treatment

cryoablation procedure using the iCLAS Cryoablation System

Clinical Study ID

NCT05416086
CS-086
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is ≥ 18 years of age
  • Planned ablation procedure according to the indication for use of the commerciallyavailable Adagio iCLAS™ Cryoablation System
  • Subject willing to comply with study requirements and give informed consent.

Exclusion

Exclusion Criteria:

  • In the opinion of the Investigator, any known contraindication to an atrial ablationprocedure with the Adagio iCLAS™ Cryoablation System as indicated in the deviceInstructions For Use (IFU).
  • Subject is enrolled in a study that has not been approved for concurrent enrollment bythe sponsor.
  • Any other condition that, in the judgment of the investigator, makes the patient apoor candidate for this procedure, the study or compliance with the protocol (includesvulnerable patient population, mental illness, addictive disease, terminal illnesswith a life expectancy of less than one year, extensive travel away from the researchcenter)

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: cryoablation procedure using the iCLAS Cryoablation System
Phase:
Study Start date:
September 03, 2021
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Onze-Lieve-Vrouw Hospital Aalst (OLV)

    Aalst, 9300
    Belgium

    Active - Recruiting

  • Universitatsklinikum Erlangen

    Erlangen, 91054
    Germany

    Active - Recruiting

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435
    Netherlands

    Active - Recruiting

  • Erasmus MC

    Rotterdam,
    Netherlands

    Active - Recruiting

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