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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05416086
• Other study ID #: CS-086
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2023
• Source: Adagio Medical
• Contact: Nabil M Jubran
• Phone: (949) 348-1188
• Email: njubran[@]adagiomedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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

Country	Name	City	State
Belgium	Onze-Lieve-Vrouw Hospital Aalst (OLV)	Aalst
Germany	Universitatsklinikum Erlangen	Erlangen
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	Erasmus MC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Adagio Medical

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome - freedom from AF	Freedom from Atrial Fibrillation (AF) recurrence during the 12-months follow-up period.	12 months
Primary	Primary outcome - freedom from AF/AT/AFL	Freedom from Atrial Arrhythmia at 12-months	12 months
Primary	Primary outcome - freedom from Device/Procedure Related Adverse Events	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