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

NCT05416086 | Terminated

• 1 other identifier: CS-086
• Study Type: interventional
• Target: 91
• Locations: 3 countries
• Sites: 4

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).

Conditions

Atrial Fibrillation; Atrial Flutter; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Primary outcome - freedom from AF

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

  12 months

• Primary outcome - freedom from AF/AT/AFL

  Freedom from Atrial Arrhythmia at 12-months

  12 months

• 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

Study Arms (1)

iCLAS Cryoablation arm

OTHER

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

Interventions

cryoablation procedure using the iCLAS Cryoablation System DEVICE

all subjects will receive a cryoablation procedure using the iCLAS Cryoablation System (catheter, stylets, and console) and warming balloon

iCLAS Cryoablation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Adagio Medical: lead

Study Sites (4)

Onze-Lieve-Vrouw Hospital Aalst (OLV)

Aalst, 9300, Belgium

Location

Universitatsklinikum Erlangen

Erlangen, 91054, Germany

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 13, 2022
• Study Start: September 3, 2021
• Primary Completion: January 28, 2025
• Study Completion: January 28, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); NL (2); BE (1)