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Treatment for Atrial Flutter

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

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 Flutter
  • Atrial Fibrillation

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
Freedom from pacemaker implant or overall device or Surgical Ablation procedures Related to Adverse Events

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Who is running the clinical trial?

AtriCure, Inc.Lead Sponsor
42 Previous Clinical Trials
18,732 Total Patients Enrolled
~12 spots leftby Sep 2025
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