This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.
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.
Study Type
OBSERVATIONAL
Enrollment
39
The AtriCure cryoICE® cryoFORMTM cryoablation probe is used in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.
Hartford Hospital
Hartford, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Northwestern University
Evanston, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
Freedom From Death, Stroke (Regardless of Level of Disability), Myocardial Infarction, and Major Bleeding Events.
Death, stroke (regardless of level of disability), myocardial infarction, and major bleeding events within 30-days of the index ablation procedure. Measured by number of patients with Treatment-Related Adverse Events.
Time frame: 30 days post procedure
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
Freedom from any documented atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) lasting \>30 seconds in duration at the last follow-up visit off antiarrhythmic therapy (except of AADs at doses not exceeding those previously failed). Measured by 24-hour Holter Monitoring.
Time frame: 12-24 months post procedure
Freedom From Any Documented AF, AFL, or AT Lasting >30 Seconds at the Last Follow-up Visit Regardless 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.
Time frame: 12-24 months post 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 in the absence of Class I or III AADs.
Time frame: 12-24 months post procedure
Acute Procedural Success Defined as Documentation of Sinus Rhythm at the End of the Procedure.
Acute procedural success defined as documentation of sinus rhythm at the end of the procedure.
Time frame: At end of procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Saint Thomas West Hospital
Nashville, Tennessee, United States