Cryo Global Registry

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02752737
• Lead Sponsor: Medtronic Cardiac Ablation Solutions

Brief Summary

Cryo Global Registry a prospective, global, multi-center, observational Post-Market Registry

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-27
• Study Start: 2016-05-02
• Primary Completion: 2024-11-29
• Study Completion: 2024-11-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-07-29
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5385

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from Atrial Fibrillation (AF) Recurrence at 12 Months	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	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	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	12 Months	Estimate device and procedure-related adverse events for cryoablation using the Arctic Front™ Cardiac Cryoablation Catheter System through 12 months.

Trial Locations

Locations (160)

Carle Foundation Hospital; 🇺🇸 Urbana, Illinois, United States

Spectrum Health Hospitals; 🇺🇸 Grand Rapids, Michigan, United States

The Lindner Research Center; 🇺🇸 Cincinnati, Ohio, United States

Doylestown Health Cardiology; 🇺🇸 Doylestown, Pennsylvania, United States

Texas Cardiac Arrhythmia Research Foundation; 🇺🇸 Austin, Texas, United States

Texas Health Research & Education Institute; 🇺🇸 Dallas, Texas, United States

Instituto Cardiovascular de Buenos Aires (ICBA); 🇦🇷 Buenos Aires, Argentina

Institituo Cardiovascular Buenos Aires (ICBA); 🇦🇷 Buenos Aires, Argentina

Hospital Universitario Fundación Favaloro; 🇦🇷 Buenos Aires, Argentina

Kepler Universitätsklinikum Med Campus III.; 🇦🇹 Linz, Austria

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