AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment

Persistent Atrial Fibrillation Clinical Trial

— ICE-AFIB  

Official title:

AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03732794
• Other study ID #: CP2018-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: December 2026

Study information

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

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and effectiveness of the AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with Left Atrial Appendage (LAA) exclusion using the AtriClip device.

Description:

The AtriCure CryoICE Ablation System is being studied to ablate cardiac tissue during surgery for the treatment of Persistent and Long-standing Persistent atrial fibrillation in open concomitant cardiac surgery. The effectiveness of the device will be demonstrated by establishing that the device effectively eliminates persistent and long-standing persistent atrial fibrillation in a clinically significant proportion of treated patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is greater than or equal to 18 years of age

2. Subject has history of persistent or long-standing persistent atrial fibrillation as defined by the 2017 Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/ European Cardiac Arrhythmia Society (ECAS) Guidelines

3. Stable Subject that is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed 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, and Coronary artery bypass procedures

4. Left Ventricular Ejection Fraction = 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as documented in patient medical history)

5. Subject is willing and able to provide written informed consent

6. Subject has a life expectancy of at least 5 years

7. Subject is willing and able to return for scheduled follow-up visits.

Exclusion Criteria:

1. Stand-alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery

2. Previous surgical Maze procedure

3. Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia, Atrioventricular (AV) nodal reentry

4. Prior cardiac surgery (Redo)

5. Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or patent foramen ovale repair, and/or atrial septal defect repair.

6. Class IV New York Heart Association (NYHA) heart failure symptoms

7. Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurological deficit

8. Documented ST-segment elevation Myocardial Infarction (MI) within the 6 weeks prior to study enrollment

9. Need for emergent cardiac surgery (i.e. cardiogenic shock)

10. Known carotid artery stenosis greater than 80%

11. Documented AF duration of greater than ten years

12. LA diameter >7 cm by Transthoracic echocardiography (TTE)

13. Current diagnosis of active systemic infection

14. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion

15. Renal failure requiring dialysis or hepatic failure

16. A known drug and/or alcohol addiction

17. Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study

18. Pregnancy or desire to get pregnant within 12-months of the study treatment

19. Preoperative need for an intra-aortic balloon pump or intravenous inotropes

20. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia

21. Subjects who have been treated with thoracic radiation

22. Subjects in current chemotherapy

23. Subjects on long term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases)

24. Subjects with known connective tissue disorders

25. Subjects with known hypertrophic obstructive cardiomyopathy

26. Subjects with known cold agglutinin

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation (AF)
• Longstanding Persistent Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• AtriCure CryoICE & AtriClip LAA Exclusion
AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University Of Maryland	Baltimore	Maryland
United States	Northwestern Medicine	Chicago	Illinois
United States	Franciscan Health	Indianapolis	Indiana
United States	St. Luke's Hospital	Kansas City	Missouri
United States	UCLA Medical Center	Los Angeles	California
United States	West Virginia University	Morgantown	West Virginia
United States	St Thomas West Hospital	Nashville	Tennessee
United States	Mount Sinai Icahn School of Medicine	New York	New York
United States	Northwell Health Systems	New York	New York
United States	NYP-Weill Cornell	New York	New York
United States	Deaconess Gateway Hospital	Newburgh	Indiana
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Joseph Hospital Health Center	Syracuse	New York
United States	Washington Adventist Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint: Freedom from AF/Atrial Flutter (AFL)/Atrial Tachycardia (AT)	Freedom from AF/AFL/AT lasting >30 seconds in duration 6 through 12-months following the ablation procedure in the absence of Class I or III antiarrhythmic drugs (AADs).	12 months
Primary	Safety Endpoint: composite acute major adverse event (MAE) rate	The composite acute major adverse event (MAE) rate, within 30-days post-procedure and deaths after 30-days if death is procedure related.	30 days
Secondary	Composite post-procedure MAE rate (Safety).	Long-term safety based on MAE rate at 12-months post-procedure	12 months
Secondary	Pacemaker implantation (Safety).	Percentage of implantation of a permanent pacemaker either in the operative period (<30 days postoperative) or at any time during follow-up period.	12 months
Secondary	Overall Serious Adverse Event (SAE) rate (Safety)	Long-term safety based on SAE rate at 12-months post-procedure	12 months
Secondary	Freedom from AF/AFL/AT in presence of previously failed Class I or III AADs (Effectiveness)	Freedom from AF/AFL/AT lasting >30 seconds in duration 12-months following the ablation procedure in presence of previously failed Class I or III AADs.	12 months
Secondary	Freedom from AF/AFL/AT regardless of Class I or III AADs (Effectiveness)	Freedom from AF/AFL/AT lasting >30 seconds in duration 12-months following the ablation procedure regardless of Class I or III AADs.	12 months
Secondary	Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score (Effectiveness)	Based on composite score (0-100). A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).; AFEQT Evaluates Health Related Quality of Life (HRQoL) across three domains Symptoms - Four questions specifically targeted to assess AF related symptoms Daily Activities - Eight questions that evaluate daily function in AF patients Treatment Concerns - Six questions that assess AF treatment concerns in patients The overall composite score and domains will be summarized by presenting the means, medians, standard deviations, interquartile ranges, minimum, and maximum	12 months
Secondary	Acute procedural success (Effectiveness)	Absence of AF at end of procedure	Intra-operative period