FREEZE-AFIB Post-Market Study

Atrial Fibrillation Clinical Trial

Official title:

Outcomes of Surgical AF Ablation Using cryoICE Cryoablation System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05089877
• Other study ID #: CP-2021-02
• Status: Active, not recruiting
• Start date: April 29, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: April 2023
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: August 1, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Northwestern University	Evanston	Illinois
United States	Hartford Hospital	Hartford	Connecticut
United States	Saint Thomas West Hospital	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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