FREEZE-AFIB Post-Market Study

Outcomes of Surgical AF Ablation Using cryoICE Cryoablation System

This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Atrial Flutter
• Intervention / Treatment: Device: Surgical Ablation

Detailed Description

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 (Actual): 39

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Hospital
    • New Haven, Connecticut, United States, 06510
      • Yale University School Of Medicine
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Saint Thomas West Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who have undergone concomitant surgical AF ablation using the CRYOF device under investigation.

Description

Inclusion Criteria:

1. Subject is greater than or equal to 18 years of age.
2. Subject has documented history of atrial fibrillation.
3. Subjects who received surgical ablation for their atrial fibrillation using CRYOF and on whom at least the following lesions were performed: Left and right pulmonary vein isolation, roof and floor lines, mitral annulus line and a connecting lesion from left atrial appendage to left pulmonary vein coronary sinus lesion and LAA exclusion , with a lesion duration of at least 2 minutes.
4. Stable subject that underwent non-emergent cardiac surgical procedure(s) on cardiopulmonary bypass including open-heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, or coronary artery bypass procedures, or atrial septal defect (ASD) repair
5. Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 90 days of enrollment as documented in patient medical history).
6. Subject is willing and able to provide written informed consent.
7. Subject is willing and able to return for scheduled follow-up visits.

Exclusion Criteria:

1. Stand-alone AF without indication(s) for concomitant CABG and/or valve surgery.
2. Previous left sided ablation procedures procedure.
3. Untreated atrial flutter and symptomatic ventricular arrythmia
4. Known carotid artery stenosis greater than 80% prior to index ablation procedure.
5. Prior history of ischemic stroke or hemorrhagic stroke
6. History of MI with ST elevation within 6 weeks prior to the index ablation
7. Documented AF duration of greater than 10 years.
8. Large left atrial size i.e., LA diameter >7 cm prior to the index ablation procedure.
9. Subjects with active systemic infection prior to index ablation procedure.
10. Subjects who had documented severe peripheral arterial occlusive disease defined as claudication with minimal exertion prior to the ablation procedure.
11. Subjects with history of renal failure requiring dialysis or hepatic failure prior to the ablation procedure.
12. A known drug and/or alcohol addiction.
13. Mental impairment or other conditions which may not allow the subject to understand the nature, significance, and scope of the study.
14. Subjects who are pregnant
15. Subjects who had preoperative need for mechanical circulatory support or intravenous inotropes.
16. Subjects who are on anti-arrhythmic drug therapy for the treatment of another arrhythmia.
17. Subjects in currently undergoing chemotherapy.
18. Subjects on long term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases).
19. Subjects who had known connective tissue disorders at the time of index ablation procedure
20. Subjects who had known hypertrophic obstructive cardiomyopathy at the time of index ablation procedure
21. Subjects with known cold agglutinin.
22. Subjects who had or tested positive for COVID-19
23. Subjects with bleeding disorders and/or inability to receive anticoagulation
24. Subjects undergoing aortic dissection surgery as index procedure.
25. Cardiac surgical re-intervention since the index cardiac surgery with concomitant AF ablation procedure

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12-24 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	At end of procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom From Pacemaker Implant or Overall Device or Surgical Ablation Procedures Related to Adverse Events	Freedom from pacemaker implant or overall device or Surgical Ablation procedures Related to Adverse Events	12-24 months post procedure

Collaborators and Investigators

• Sponsor: AtriCure, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Surgical ablation; Cryo probe
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter
• Other Study ID Numbers: CP-2021-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No