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

Adagio Medical

Status

Enrolling

Conditions

Paroxysmal Atrial Fibrillation

Atrial Flutter

Atrial Fibrillation

Persistent Atrial Fibrillation

Treatments

Device: cryoablation procedure using the iCLAS Cryoablation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05416086

CS-086

Details and patient eligibility

About

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).

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

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)