Stroke Feasibility Study

• Sponsor: AtriCure, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01997905
• Collaborator: (none)
• Enrollment: 13
• Locations: 7
• Arm: 1
• Duration (Months): 19
• Patients Per Site: 1.9
• Patients Per Site Per Month: 0.1

Study Details

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
• 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: Jan 1, 2014
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Aug 1, 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 [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 [Immediate to 3-months post-index procedure]

   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.

Secondary Outcome Measures

1. Rate of Stroke and Non-CNS Systemic Embolism [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: Stroke (ischemic ) Non-CNS (Central Nervous System) systemic embolism.

2. Serious Device or Procedure Related Adverse Event Rate [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Patient is considered an acceptable surgical candidate, including use of general anesthesia.

2. 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

	Site	City	State	Country	Postal Code
1	St. Helena Hospital	St. Helena	California	United States	94574
2	Mercy Hospital	Miami	Florida	United States	33133
3	Franciscan St. Francis Health	Indianapolis	Indiana	United States	46237
4	Good Samaritan Hospital	Cincinnati	Ohio	United States	45220
5	Houston Methodist Hospital	Houston	Texas	United States	77030
6	University of Virginia	Charlottesville	Virginia	United States	22908
7	Aspirus	Wausau	Wisconsin	United States	54401

Sponsors and Collaborators

• AtriCure, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AtriCure, Inc.
• ClinicalTrials.gov Identifier: NCT01997905
• Other Study ID Numbers: CP2011-2
• First Posted: Nov 28, 2013
• Last Update Posted: Dec 14, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by AtriCure, Inc.: 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
• Additional relevant MeSH terms: Atrial Fibrillation; Protein S

Study Results

Participant Flow

Recruitment Details	The first subject was enrolled (defined as signed informed consent) on March 25, 2014. The last subject completed their final visit as of July 31, 2015. A total of 13 subjects were enrolled from 4 sites. Of the 13 enrolled subjects, 10 were treated (defined as attempted surgery) with the investigational device.

Arm/Group Title	AtriClip LAA Exclusion Device
Arm/Group Description	AtriClip delivered via minimally invasive surgical procedure AtriClip LAA Exclusion Device
Period Title: Overall Study
STARTED	13
Baseline Completed	11
COMPLETED	10
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	AtriClip LAA Exclusion Device
Arm/Group Description	AtriClip delivered via minimally invasive surgical procedure AtriClip LAA Exclusion Device
Overall Participants	11
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 9.1%
>=65 years	10 90.9%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	72 (8.85)
Gender (Count of Participants)
Female	4 36.4%
Male	7 63.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 9.1%
Not Hispanic or Latino	10 90.9%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	11 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
NYHA Functional Class (participants) [Number]
I (No symptoms and no limitations)	6 54.5%
II (Mild symptoms and slight limitation)	3 27.3%
III (Marked limitation)	0 0%
IV (Severe limitations)	0 0%
No Heart Block	1 9.1%
Not Reported	1 9.1%
CHADS2 Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.9 (0.88)
CHA2DSVAS Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.6 (0.84)
HAS-BLED Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.6 (0.70)

Outcome Measures

1. Primary Outcome

Title	Number of Serious Adverse Events Within 30 Days Post-Index Procedure
Description	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).
Time Frame	30 days post-index procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AtriClip LAA Exclusion Device
Arm/Group Description	AtriClip delivered via minimally invasive surgical procedure AtriClip LAA Exclusion Device
Measure Participants	10
Number [participants]	0 0%

2. Primary Outcome

Title	Composite Left Atrial Appendage Placement and Exclusion Success
Description	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.
Time Frame	Immediate to 3-months post-index procedure

Outcome Measure Data

Analysis Population Description

Ten (10) patients were treated, however the AtriClip® device was not implanted in one (1) patient.

Arm/Group Title	AtriClip LAA Exclusion Device
Arm/Group Description	AtriClip delivered via minimally invasive surgical procedure AtriClip LAA Exclusion Device
Measure Participants	9
Number [participants]	8 72.7%

3. Secondary Outcome

Title	Rate of Stroke and Non-CNS Systemic Embolism
Description	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.
Time Frame	3 months and 6 months post-index procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AtriClip LAA Exclusion Device
Arm/Group Description	AtriClip delivered via minimally invasive surgical procedure AtriClip LAA Exclusion Device
Measure Participants	10
Number [participants]	0 0%

4. Secondary Outcome

Title	Serious Device or Procedure Related Adverse Event Rate
Description	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.
Time Frame	3 month and 6 month post-index procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AtriClip LAA Exclusion Device
Arm/Group Description	AtriClip delivered via minimally invasive surgical procedure AtriClip LAA Exclusion Device
Measure Participants	10
Number [participants]	0 0%

5. Secondary Outcome

Title	Overall Serious Adverse Event Rate
Description	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.
Time Frame	3 month and 6 month Post Index Procedure

Outcome Measure Data

Analysis Population Description

All treated patients.

Arm/Group Title	AtriClip LAA Exclusion Device
Arm/Group Description	AtriClip delivered via minimally invasive surgical procedure AtriClip LAA Exclusion Device
Measure Participants	10
Cardiac Disorder	3 27.3%
General Disorder	1 9.1%
Infections and Infestations	2 18.2%
Neoplasms Benign (Carcinoid Tumor Pulmonary)	1 9.1%
Respiratory Failure	1 9.1%

6. Secondary Outcome

Title	Overall Adverse Event Rate
Description	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.
Time Frame	3 month and 6 month post-index procedure

Outcome Measure Data

Analysis Population Description

All treated patients.

Arm/Group Title	AtriClip LAA Exclusion Device
Arm/Group Description	AtriClip delivered via minimally invasive surgical procedure AtriClip LAA Exclusion Device
Measure Participants	10
Blood and Lymphatic System Disorders (Anaemia)	3 27.3%
Cardiac Disorder	3 27.3%
Eye Disorder (Cataract)	1 9.1%
Gastrointestinal Disorder	3 27.3%
General Disorder	3 27.3%
Immune Disorder (Seasonal Allergy)	1 9.1%
Infections and Infestations	5 45.5%
Injury (Accident at Home, Radius Fracture)	2 18.2%
Investigations	2 18.2%
Metabolism and Nutrition Disorder	1 9.1%
Neoplasms Benign (Carcinoid Tumor Pulmonary)	1 9.1%
Nervous System Disorder	1 9.1%
Psychiatric Disorder	1 9.1%
Renal and Urinary Disorder	2 18.2%
Respiratory Disorder	4 36.4%
Surgical and Medical Procedure	1 9.1%
Vascular Disorder	2 18.2%

Adverse Events

Time Frame	Incidence of Serious Adverse Events reported during the study
Arm/Group Title	AtriClip LAA Exclusion Device
Arm/Group Description	AtriClip delivered via minimally invasive surgical procedure AtriClip LAA Exclusion Device
All Cause Mortality
	AtriClip LAA Exclusion Device
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	AtriClip LAA Exclusion Device
	Affected / at Risk (%)	# Events
Total	5/10 (50%)
Cardiac disorders
Atrial Fibrillation	2/10 (20%)	2
Sick sinus syndrome	1/10 (10%)	1
General disorders
Chest pain	1/10 (10%)	1
Infections and infestations
Pnemonia	1/10 (10%)	1
Respiratory Tract Infection	1/10 (10%)	1
Sepsis	1/10 (10%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carinoid tumor pulmonary	1/10 (10%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/10 (10%)	1
Other (Not Including Serious) Adverse Events
	AtriClip LAA Exclusion Device
	Affected / at Risk (%)	# Events
Total	8/10 (80%)
Blood and lymphatic system disorders
Anaemia	3/10 (30%)	3
Cardiac disorders
Cardiovascular Deconditioning	3/10 (30%)	3
Diastolic Dysfunction	1/10 (10%)	1
Sick Sinus Sundrome	1/10 (10%)	1
Eye disorders
Cataract	1/10 (10%)	1
Gastrointestinal disorders
Ascites	1/10 (10%)	1
Constipation	1/10 (10%)	1
Haemorrhoids	1/10 (10%)	1
Rectal Haemorrhage	1/10 (10%)	1
General disorders
Pyrexia	2/10 (20%)	2
Chest Pain	1/10 (10%)	1
Immune system disorders
Seasonal Allergy	1/10 (10%)	1
Infections and infestations
Bronchitis	1/10 (10%)	1
Pharyngitis	1/10 (10%)	1
Upper Respiratory Tract Infection	1/10 (10%)	1
Urinary Tract Infection	1/10 (10%)	1
Injury, poisoning and procedural complications
Accident at Home	1/10 (10%)	1
Radius Fracture	1/10 (10%)	1
Investigations
Biopsy Lung Abnormal	1/10 (10%)	1
Troponin Increased	1/10 (10%)	1
Metabolism and nutrition disorders
Electrolyte Imbalance	1/10 (10%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carinoid Tumor Pulmonary	1/10 (10%)	1
Nervous system disorders
Syncope	1/10 (10%)	1
Pregnancy, puerperium and perinatal conditions
Altered State of Consciousness	1/10 (10%)	1
Psychiatric disorders
Anxiety	1/10 (10%)	1
Renal and urinary disorders
Diabetic Nephropathy	1/10 (10%)	1
Oliguria	1/10 (10%)	1
Renal Colic	1/10 (10%)	1
Renal Failure	1/10 (10%)	1
Renal Failure Acute	1/10 (10%)	1
Respiratory, thoracic and mediastinal disorders
Hypoxia	2/10 (20%)	2
Atelectasis	1/10 (10%)	1
Epistaxis	1/10 (10%)	1
Pulmonary Hypertension	1/10 (10%)	1
Respiratory Distress	1/10 (10%)	1
Respiatory Failure	1/10 (10%)	1
Surgical and medical procedures
Cataract Operation	1/10 (10%)	1
Vascular disorders
Haematoma	1/10 (10%)	1
Hypotension	1/10 (10%)	1
Thrombophlebitis	1/10 (10%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.