Stroke Feasibility Study

• ClinicalTrials.gov Identifier: NCT01997905
• Recruitment Status: Completed
• First Posted: November 28, 2013
• Results First Posted: October 21, 2016
• Last Update Posted: December 14, 2016
• Sponsor: AtriCure, Inc.
• Information provided by (Responsible Party): AtriCure, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation; AFib	Device: AtriClip LAA Exclusion Device	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: January 2014
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Number of Serious Adverse Events Within 30 Days Post-Index Procedure [ Time Frame: 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).
2. Composite Left Atrial Appendage Placement and Exclusion Success [ Time Frame: Immediate to 3-months post-index procedure ]

   Primary Efficacy endpoint is a success/failure endpoint with success requiring all of the following:

   1. Patient Technical Success: The ability to successfully implant an AtriClip device at the LAA in a patient.
   2. 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. 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.

Secondary Outcome Measures :

1. Rate of Stroke and Non-CNS Systemic Embolism [ Time Frame: 3 months and 6 months post-index procedure ]

   The secondary efficacy endpoints will be a composite of the following events within 3 months and 6 months post-index procedure:

   1. Stroke (ischemic )
   2. Non-CNS (Central Nervous System) systemic embolism.
2. Serious Device or Procedure Related Adverse Event Rate [ Time Frame: 3 month and 6 month post-index procedure ]
   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. Overall Serious Adverse Event Rate [ Time Frame: 3 month and 6 month Post Index Procedure ]
   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.
4. Overall Adverse Event Rate [ Time Frame: 3 month and 6 month post-index procedure ]
   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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, California

St. Helena Hospital

St. Helena, California, United States, 94574

United States, Florida

Mercy Hospital

Miami, Florida, United States, 33133

United States, Indiana

Franciscan St. Francis Health

Indianapolis, Indiana, United States, 46237

United States, Ohio

Good Samaritan Hospital

Cincinnati, Ohio, United States, 45220

United States, Texas

Houston Methodist Hospital

Houston, Texas, United States, 77030

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22908

United States, Wisconsin

Aspirus

Wausau, Wisconsin, United States, 54401

Sponsors and Collaborators

AtriCure, Inc.

Investigators

• Principal Investigator: Basel Ramlawi, MD; Methodist Hospital Houston

More Information

• Responsible Party: AtriCure, Inc.
• ClinicalTrials.gov Identifier: NCT01997905
• Other Study ID Numbers: CP2011-2
• First Posted: November 28, 2013
• Results First Posted: October 21, 2016
• Last Update Posted: December 14, 2016
• Last Verified: October 2016

Keywords provided by AtriCure, Inc.:

Stroke; study; Left Atrial Appendage; LAA; Atrial Fibrillation; AFib; AF; IRB approved; clinical; TIA; contraindication to oral anticoagulation therapy; Arrhythmias, Cardiac; OAC; trial; LAA occlusion; occluded; prevent

Additional relevant MeSH terms:

Atrial Fibrillation; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Protein S; Anticoagulants