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

• Sponsor: Adagio Medical (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05416086
• Collaborator: (none)
• Enrollment: 150
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 32.9
• Patients Per Site: 37.5
• Patients Per Site Per Month: 1.1

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
Atrial Fibrillation; Atrial Flutter; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation	Device: cryoablation procedure using the iCLAS Cryoablation System	N/A

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: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adagio Medical
• ClinicalTrials.gov Identifier: NCT05416086
• 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: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation; Atrial Flutter

Study Results

No Results Posted as of Jun 13, 2022