Stroke Feasibility Study

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997905
• Other study ID #: CP2011-2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 21, 2013
• Last updated: August 24, 2015
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AFib
• Atrial Fibrillation

Intervention

Device:
• AtriClip LAA Exclusion Device

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	Houston Methodist Hospital	Houston	Texas
United States	Franciscan St. Francis Health	Indianapolis	Indiana
United States	Mercy Hospital	Miami	Florida
United States	St. Helena Hospital	St. Helena	California
United States	Aspirus	Wausau	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes