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FREEZE-AFIB Post-Market Study

N/A

Waitlist Available

Research Sponsored by AtriCure, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-24 months post procedure

Awards & highlights

No Placebo-Only Group

Summary

This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device. Specifically, data from this study will be used for submission to regulatory authorities in Europe, China and other geographies as needed.

Eligible Conditions

Atrial Fibrillation
Atrial Flutter

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-24 months post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-24 months post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-24 months post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hemorrhage

Freedom from any documented AF, AFL or AT lasting >30 seconds in the duration of the last follow-up visit off antiarrhythmic therapy (except of AADs at doses not exceeding those previously failed

Secondary study objectives

Interventional procedure

Freedom from any documented AF, AFL, or AT lasting >30 seconds at the last follow-up visit in the absence of Class I or III AADs.

Freedom from any documented AF, AFL, or AT lasting >30 seconds at the last follow-up visit regardless of Class I or III AADs

Other study objectives

Freedom from pacemaker implant or overall device or Surgical Ablation procedures Related to Adverse Events