FREEZE-AFIB Post-Market Study

NCT05089877 | Completed Results

• 1 other identifier: CP-2021-02
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Atrial Fibrillation; Atrial Flutter

Keywords

Surgical ablation; Cryo probe

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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.

  12-24 months post procedure

• Acute Procedural Success Defined as Documentation of Sinus Rhythm at the End of the Procedure.

  At end of procedure

Other Outcomes (1)

• Freedom From Pacemaker Implant or Overall Device or Surgical Ablation Procedures Related to Adverse Events

  12-24 months post procedure

Interventions

Surgical Ablation DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Subject is greater than or equal to 18 years of age.
• Subject has documented history of atrial fibrillation.
• 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
• Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 90 days of enrollment as documented in patient medical history).
• Subject is willing and able to provide written informed consent.
• Subject is willing and able to return for scheduled follow-up visits.

You may not qualify if:

• Stand-alone AF without indication(s) for concomitant CABG and/or valve surgery.
• Previous left sided ablation procedures procedure.
• Untreated atrial flutter and symptomatic ventricular arrythmia
• Known carotid artery stenosis greater than 80% prior to index ablation procedure.
• Prior history of ischemic stroke or hemorrhagic stroke
• History of MI with ST elevation within 6 weeks prior to the index ablation
• Documented AF duration of greater than 10 years.
• Large left atrial size i.e., LA diameter \>7 cm prior to the index ablation procedure.
• Subjects with active systemic infection prior to index ablation procedure.
• Subjects who had documented severe peripheral arterial occlusive disease defined as claudication with minimal exertion prior to the ablation procedure.
• Subjects with history of renal failure requiring dialysis or hepatic failure prior to the ablation procedure.
• A known drug and/or alcohol addiction.
• Mental impairment or other conditions which may not allow the subject to understand the nature, significance, and scope of the study.
• Subjects who are pregnant
• Subjects who had preoperative need for mechanical circulatory support or intravenous inotropes.

Sponsors & Collaborators

• AtriCure, Inc.: lead

Study Sites (6)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Saint Thomas West Hospital

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nfii Ndikintum, VP of Clinical Affairs and Biometerics
• Organization: AtriCure

NNdikintum@atricure.com

5136448192

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: October 22, 2021
• Study Start: April 29, 2022
• Primary Completion: March 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)