Cryo Global Registry

Medtronic Cardiac Ablation Solutions5,385 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

5,385

Conditions

Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (163)

Outcomes

Primary Outcomes

Freedom from Atrial Fibrillation (AF) Recurrence at 12 Months

Estimate the 12 month freedom from AF recurrence using the Arctic Front™ Cardiac Cryoablation Catheter System

Time frame: 12 Months

Freedom from Atrial Arrhythmia at 12 Months

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

Time frame: 12 Months

Freedom from Arrythmias at 12 months

Estimate the 12-month freedom from arrythmias treated using the Freezor™ Family of Cardiac Cryoablation Catheters.

Time frame: 12 Months

Freedom from Device / Procedure Related Adverse Events

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

Time frame: 12 Months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 153 more locations