Stroke Feasibility Study

Feasibility Clinical Investigation of a Minimally Invasive Surgically Deployed AtriCure AtriClip Left Atrial Appendage Exclusion System for Stroke Prophylaxis in Patients With Non-Valvular Atrial Fibrillation and in Whom Long Term Oral Anticoagulation Therapy is Medically Contraindicated

This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who are unable to take Oral Anticoagulants.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; AFib
• Intervention / Treatment: Device: AtriClip LAA Exclusion Device

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • St. Helena, California, United States, 94574
      • St. Helena Hospital
  • Florida
    • Miami, Florida, United States, 33133
      • Mercy Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan St. Francis Health
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
  • Wisconsin
    • Wausau, Wisconsin, United States, 54401
      • Aspirus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is ≥ 18 years and ≤ 80 years of age.
2. Patient has electrocardiographically confirmed non-valvular atrial fibrillation (paroxysmal, persistent, or longstanding persistent AF).
3. CHADS2 or CHA2DS2VASc score ≥2.

4. Patient has medical contraindication to long term anticoagulant therapy (OAC), defined as one or more of the following:

   • history of intracranial bleeding (e.g. due to amyloid angiopathy or other condition) which renders patient unsafe for OAC;
   • history of gastrointestinal, genitourinary, or respiratory tract bleeding due to permanent condition which renders patient unsafe for OAC;
   • HAS-BLED Score ≥ 3.
5. Patient is considered an acceptable surgical candidate, including use of general anesthesia.
6. Female patients must be of non-child bearing potential, or have a negative pregnancy test within 7 days prior to index procedure.

Exclusion Criteria:

1. Stroke within 30 days, or TIA within 3 days, respectively, prior to index procedure.
2. Documented medical history of any penetrating trauma to thorax, or blunt trauma to thorax which resulted in a left pneumothorax or left hemothorax.
3. Myocardial infarction within 60 days prior to index procedure.
4. NYHA Class IV heart failure.
5. Ejection fraction < 40% (based on baseline transthoracic echocardiography (TTE)).
6. Prior attempted obliteration of left atrial appendage (percutaneous or open cardiac surgery).
7. Previous catheter ablation with perforation or complication.
8. Prior open cardiac surgery, or percutaneous coronary intervention with associated unintended cardiac perforation, or pericardial adhesions are suspected.
9. History of pericarditis or pericardiocentesis.
10. Active infection, septicemia, or fever of unknown origin.
11. Concomitant elective surgical procedure (in addition to AtriClip placement) at the time of index procedure.
12. Planned atrial arrhythmia ablation procedure within six months following index procedure.
13. Underlying structural heart disease requiring planned surgical treatment within six months following the index procedure.
14. Cardiac or thoracic surgical procedure within the thirty days prior to index procedure.
15. Anticoagulation therapy for other medical condition (i.e. deep vein thrombosis) is required.
16. Patient unable to discontinue thienopyridines (e.g. clopidogrel) or non-ASA antiplatelet agents 4 days pre-operatively and abstain for at least 2 days post-operatively.
17. Renal Failure as defined by creatinine > 2.0 mg/dl (> 152.5 umol/L) and/or need for dialysis.
18. Known carotid artery diameter stenosis greater than 80%.
19. Patient has symptomatic or high-grade carotid disease (>70% bilaterally).
20. Patient unable or unwilling to undergo transesophageal echocardiography (TEE).
21. Presence of thrombus in the left atrium or LAA, as determined by baseline TTE or Computed Tomography Angiogram (CTA).
22. Documented history of thrombophilic disorder, with diagnosis established via previous objective testing (e.g. familial screening for thrombophilia).
23. Moderate to Severe Chronic Obstructive Pulmonary Disease (FEV1 or VC<70% predicted) or intolerant of single lung ventilation.
24. History of Hypercoagulopathy
25. Body Mass Index (BMI) > 35.
26. Other medical illness or comorbidity that may cause non-compliance with the protocol, confound data interpretation (e.g. severe dementia), or limited life expectancy (i.e. < 3 months).
27. Enrolled in another investigational device or drug study at the time of enrollment and during the course of the study.
28. Psychiatric disorder which in the judgment of the investigator could interfere with informed consent, completion of tests, therapy, or follow-up.
29. Patient is pregnant or intends to become pregnant within 6 months post-index procedure.

Intraoperative Exclusion Criteria

1. Left atrial appendage width < 29mm or > 50mm, based on TEE imaging.
2. Presence of thrombus in the left atrium or LAA based on TEE imaging.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AtriClip LAA Exclusion Device; AtriClip delivered via minimally invasive surgical procedure	Device: AtriClip LAA Exclusion Device; Other Names: LAAØ; PRO1; AtriClip™ LAA Exclusion System; AtriClip™ LAA Exclusion System w/ preloaded Gillinov-Cosgrove™ Clip; AtriClip LAA Exclusion System and Delivery System (LAAØ); AtriClip LAA Exclusion System and Delivery System (PRO1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Serious Adverse Events Within 30 Days Post-Index Procedure	The primary safety endpoint consists of the following serious adverse events within 30 days post-index procedure (unless otherwise noted), as adjudicated by Independent Physician Adjudicator: Serious Injury to the cardiac structure or other body structure deemed to be related to the delivery or placement of the Clip; Cardiac-Related Death, Myocardial Infarction, or Ischemic Stroke; Major bleeding (defined as requiring re-operation and/or transfusion (> 2 U packed red blood cells (PRBC)) within any 24 hour period during the first 2 days post-index procedure or at any time point if attributed to the device/index procedure).	30 days post-index procedure
Composite Left Atrial Appendage Placement and Exclusion Success	Primary Efficacy endpoint is a success/failure endpoint with success requiring all of the following: Patient Technical Success: The ability to successfully implant an AtriClip device at the LAA in a patient.; Intra-Procedural Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (<3 mm residual communication with LAA and <10 mm residual pocket) between the LA and LAA, assessed intra-procedurally by TEE.; 3 Month Follow-Up Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (<3 mm residual communication with LAA and < 10mm residual pocket) between the LA and LAA at >=3 month TEE or CTA evaluation.	Immediate to 3-months post-index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Stroke and Non-CNS Systemic Embolism	The secondary efficacy endpoints will be a composite of the following events within 3 months and 6 months post-index procedure: Stroke (ischemic ); Non-CNS (Central Nervous System) systemic embolism.	3 months and 6 months post-index procedure
Serious Device or Procedure Related Adverse Event Rate	Overall Serious Device or Procedure Related Adverse Event Rate: Incidence of all serious device or procedure related adverse events observed through the 3 month and 6 month follow-up assessments as adjudicated by Independent Physician Adjudicator.	3 month and 6 month post-index procedure
Overall Serious Adverse Event Rate	Overall Serious Adverse Event Rate: Incidence of all serious adverse events, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.	3 month and 6 month Post Index Procedure
Overall Adverse Event Rate	Overall Adverse Event Rate: Incidence of all device and procedure related adverse events and any neurological related AEs, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.	3 month and 6 month post-index procedure

Collaborators and Investigators

• Sponsor: AtriCure, Inc.
• Investigators: Principal Investigator: Basel Ramlawi, MD, Methodist Hospital Houston

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: November 25, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Estimate): December 14, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Stroke; Atrial Fibrillation; Left Atrial Appendage; trial; TIA; clinical; AF; study; Arrhythmias, Cardiac; LAA; AFib; IRB approved; contraindication to oral anticoagulation therapy; OAC; LAA occlusion; occluded; prevent
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Anticoagulants; Protein S
• Other Study ID Numbers: CP2011-2