Clinical trial NCT01997905: Stroke Feasibility Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Atrial Fibrillation
AFib
Keywords: Left Atrial Appendage
LAA
Atrial Fibrillation
AFib
AF
IRB approved
clinical
Stroke
TIA
contraindication to oral anticoagulation therapy
Arrhythmias, Cardiac
OAC
trial
study
LAA occlusion
occluded
prevent
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Serious Adverse Events Within 30 Days Post-Index Procedure
timeFrame: 30 days post-index procedure
measure: Composite Left Atrial Appendage Placement and Exclusion Success
timeFrame: Immediate to 3-months post-index procedure
Secondary outcomes:
measure: Rate of Stroke and Non-CNS Systemic Embolism
timeFrame: 3 months and 6 months post-index procedure
measure: Serious Device or Procedure Related Adverse Event Rate
timeFrame: 3 month and 6 month post-index procedure
measure: Overall Serious Adverse Event Rate
timeFrame: 3 month and 6 month Post Index Procedure
measure: Overall Adverse Event Rate
timeFrame: 3 month and 6 month post-index procedure
Other outcomes:
Locations:
city: St. Helena
country: United States
facility: St. Helena Hospital
state: California
city: Miami
country: United States
facility: Mercy Hospital
state: Florida
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health
state: Indiana
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Wausau
country: United States
facility: Aspirus
state: Wisconsin
Study officials:
affiliation: Methodist Hospital Houston
name: Basel Ramlawi, MD
role: PRINCIPAL_INVESTIGATOR
References: