Stroke Feasibility Study

Conditions:Atrial Fibrillation, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Age Range:18 - 80
Start Date:January 2014
End Date:August 2015

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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.

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

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

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

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

15. Anticoagulation therapy for other medical condition (i.e. deep vein thrombosis) is

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

17. Renal Failure as defined by creatinine > 2.0 mg/dl (> 152.5 umol/L) and/or need for

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

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.
We found this trial at
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
Charlottesville, VA
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Cincinnati, Ohio 45220
Cincinnati, OH
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
Houston, TX
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Indianapolis, Indiana 46237
Indianapolis, IN
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Miami, Florida 33133
Miami, FL
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St. Helena, California 94574
St. Helena, CA
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Wausau, Wisconsin 54401
Wausau, WI
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