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Cryo AF Global Registry

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ClinicalTrials.gov Identifier: NCT02752737
Recruitment Status : Recruiting
First Posted : April 27, 2016
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
Cryo AF Global Registry a prospective, global, multi-center, observational Post-Market Registry

Condition or disease
Atrial Fibrillation

Detailed Description:
The Cryo AF 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Cryo AF Global Registry
Study Start Date : May 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects 18 years or older with a planned procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752737


Contacts
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Contact: Scott Sarazin 7635262817 scott.a.sarazin@medtronic.com
Contact: Laura Seiberlich 7635267851

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Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Study Director: Brien Neudeck Medtronic Clinical Research Director

Additional Information:

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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02752737     History of Changes
Other Study ID Numbers: Cryo AF Global Registry
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes