Cryo Global Registry | Clinical Trial

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Fundación Favaloro, Buenos Aires, Argentina

About this study

The Cryo Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to evaluate and describe clinical performance and safety data in a broad patient population treated with a commercially available Arctic Front™ Family of Cardiac Cryoablation Catheters (hereafter referred to as "Arctic Front™ Cardiac Cryoablation Catheter System"). The cryoballoon ablation(CBA) procedure will be performed according to routine hospital practice. The study is expected to have a 24 month enrollment period. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject is ≥ 18 years of age or minimum age as required by local regulations
Planned procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter
Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements

Exclusion criteria

Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
Subject with exclusion criteria required by local law

Treatment and study plan

Primary outcomes

Freedom from Atrial Fibrillation (AF) Recurrence at 12 Months

Time frame: 12 Months

Estimate the 12 month freedom from AF recurrence using the Arctic Front™ Cardiac Cryoablation Catheter System
Freedom from Atrial Arrhythmia at 12 Months

Time frame: 12 Months

Estimate the 12 month freedom from AF / Atrial Flutter (AFL)/ Atrial Tachycardia (AT) using the Arctic Front™ Cardiac Cryoablation Catheter System.
Freedom from Arrythmias at 12 months

Time frame: 12 Months

Estimate the 12-month freedom from arrythmias treated using the Freezor™ Family of Cardiac Cryoablation Catheters.
Freedom from Device / Procedure Related Adverse Events

Time frame: 12 Months

Estimate device and procedure-related adverse events for cryoablation using the Arctic Front™ Cardiac Cryoablation Catheter System through 12 months.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Ablation Solutions

Industry

Registry information

Official study title

Cryo Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform

Important dates

Study start: 2016
Primary completion: 2024
Study completion: 2024
First posted: Apr 27, 2016
Registry last updated: Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed