Clinical trial NCT03732794: AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment
Official title: AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Persistent Atrial Fibrillation
Longstanding Persistent Atrial Fibrillation
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Effectiveness Endpoint: Freedom from AF/Atrial Flutter (AFL)/Atrial Tachycardia (AT)
timeFrame: 12 months
measure: Safety Endpoint: composite acute major adverse event (MAE) rate
timeFrame: 30 days
Secondary outcomes:
measure: Composite post-procedure MAE rate (Safety).
timeFrame: 12 months
measure: Pacemaker implantation (Safety).
timeFrame: 12 months
measure: Overall Serious Adverse Event (SAE) rate (Safety)
timeFrame: 12 months
measure: Freedom from AF/AFL/AT in presence of previously failed Class I or III AADs (Effectiveness)
timeFrame: 12 months
measure: Freedom from AF/AFL/AT regardless of Class I or III AADs (Effectiveness)
timeFrame: 12 months
measure: Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score (Effectiveness)
timeFrame: 12 months
measure: Acute procedural success (Effectiveness)
timeFrame: Intra-operative period
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Washington
country: United States
facility: Washington Adventist Hospital
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan Health
state: Indiana
city: Newburgh
country: United States
facility: Deaconess Gateway Hospital
state: Indiana
city: Baltimore
country: United States
facility: University Of Maryland
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: New York
country: United States
facility: Mount Sinai Icahn School of Medicine
state: New York
city: New York
country: United States
facility: NYP-Weill Cornell
state: New York
city: New York
country: United States
facility: Northwell Health Systems
state: New York
city: Syracuse
country: United States
facility: St. Joseph Hospital Health Center
state: New York
city: Nashville
country: United States
facility: St Thomas West Hospital
state: Tennessee
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Washington Adventist Hospital
name: Niv Ad, MD
role: PRINCIPAL_INVESTIGATOR
References: