FREEZE-AFIB Post-Market Study

NCT ID: NCT05089877

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-29
• Study Completion Date: 2023-12-31

Brief Summary

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

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.

Conditions

Atrial Fibrillation; Atrial Flutter

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Interventions

Surgical Ablation

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AtriCure, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Saint Thomas West Hospital

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP-2021-02

Identifier Type: -

Identifier Source: org_study_id