Clinical trial NCT05089877: FREEZE-AFIB Post-Market Study
Official title: Outcomes of Surgical AF Ablation Using cryoICE Cryoablation System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Atrial Flutter
Keywords: Surgical ablation
Cryo probe
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have undergone concomitant surgical AF ablation using the CRYOF device under investigation.

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.

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

Primary outcomes:
measure: Freedom From Death, Stroke (Regardless of Level of Disability), Myocardial Infarction, and Major Bleeding Events.
timeFrame: 30 days post procedure
measure: 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
timeFrame: 12-24 months post procedure
Secondary outcomes:
measure: Freedom From Any Documented AF, AFL, or AT Lasting >30 Seconds at the Last Follow-up Visit Regardless of Class I or III AADs
timeFrame: 12-24 months post procedure
measure: 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.
timeFrame: 12-24 months post procedure
measure: Acute Procedural Success Defined as Documentation of Sinus Rhythm at the End of the Procedure.
timeFrame: At end of procedure
Other outcomes:
measure: Freedom From Pacemaker Implant or Overall Device or Surgical Ablation Procedures Related to Adverse Events
timeFrame: 12-24 months post procedure
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Saint Thomas West Hospital
state: Tennessee
Study officials:
References: