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Stroke Feasibility Study

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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:
Information provided by (Responsible Party):
AtriCure, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Atrial Fibrillation
AFib
Intervention Device: AtriClip LAA Exclusion Device
Enrollment 13
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.
Pre-assignment Details  
Arm/Group Title AtriClip LAA Exclusion Device
Hide 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
Arm/Group Title AtriClip LAA Exclusion Device
Hide Arm/Group Description

AtriClip delivered via minimally invasive surgical procedure

AtriClip LAA Exclusion Device

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
   9.1%
>=65 years
10
  90.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
72  (8.85)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
4
  36.4%
Male
7
  63.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Hispanic or Latino
1
   9.1%
Not Hispanic or Latino
10
  90.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
11
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
NYHA Functional Class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants
I (No symptoms and no limitations) 6
II (Mild symptoms and slight limitation) 3
III (Marked limitation) 0
IV (Severe limitations) 0
No Heart Block 1
Not Reported 1
[1]
Measure Description: Doctors usually classify patients' heart failure according to the severity of their symptoms. The table below describes the most commonly used classification system, the New York Heart Association (NYHA) Functional Classification. It places patients in one of four categories based on how much they are limited during physical activity(http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/Classes-of-Heart-Failure_UCM_306328_Article.jsp#.V8WM3md4epo). The higher the category, the more severe the symptoms.
CHADS2 Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants
2.9  (0.88)
[1]
Measure Description: CHADS2 is based on the following: Congestive Heart Failure, Hypertension, Age (75 years or older), Diabetes Mellitus, and Stroke (history of stroke or transient ischemic attack). For each factor that is present, the patient receives one point for a total of 6 points. The higher the CHADS2 score the higher the stroke risk.
CHA2DSVAS Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants
4.6  (0.84)
[1]
Measure Description: CHA2DS2-VASc included additional 'stroke risk modifier' risk factors to the CHADS2. CHA2DS2-VASc score was extended to include: age 65-74, female gender and vascular disease. In the CHA2DS2-VASc score, 'age 75 and above' also has extra weight, with 2 points. The maximum CHA2DS2-VASc score is 9 (for age, either the patient is ≥75 years and gets two points, is between 65-74 and gets one point, or is under 65 and get no point). The higher the CHA2DS2-VASc score, the higher the stroke risk.
HAS-BLED Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants
3.6  (0.70)
[1]
Measure Description: A risk score to estimate the one year risk of major bleeding (i.e. intracranial, requiring hospitalization, hemoglobin decrease> 2g/L, and/or transfusion) in patients with atrial fibrillation. HAS-BLED score can range from 0 to 9 points, depending upon the number of risk factors for a given patient. HAS-BLED includes the following factors: Hypertension, Abnormal Kidney and/or Liver Function, Stroke (previous history of stroke, especially deep brain (lacunar) stroke), Bleeding, Labile INR, Elderly (>65 years) and Drugs and/or alcohol. The higher the score, the higher the risk of bleeding.
1.Primary Outcome
Title Number of Serious Adverse Events Within 30 Days Post-Index Procedure
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AtriClip LAA Exclusion Device
Hide Arm/Group Description:

AtriClip delivered via minimally invasive surgical procedure

AtriClip LAA Exclusion Device

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
0
2.Primary Outcome
Title Composite Left Atrial Appendage Placement and Exclusion Success
Hide Description

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.
Time Frame Immediate to 3-months post-index procedure
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:

AtriClip delivered via minimally invasive surgical procedure

AtriClip LAA Exclusion Device

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
8
3.Secondary Outcome
Title Rate of Stroke and Non-CNS Systemic Embolism
Hide Description

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.
Time Frame 3 months and 6 months post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AtriClip LAA Exclusion Device
Hide Arm/Group Description:

AtriClip delivered via minimally invasive surgical procedure

AtriClip LAA Exclusion Device

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
0
4.Secondary Outcome
Title Serious Device or Procedure Related Adverse Event Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AtriClip LAA Exclusion Device
Hide Arm/Group Description:

AtriClip delivered via minimally invasive surgical procedure

AtriClip LAA Exclusion Device

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
0
5.Secondary Outcome
Title Overall Serious Adverse Event Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients.
Arm/Group Title AtriClip LAA Exclusion Device
Hide Arm/Group Description:

AtriClip delivered via minimally invasive surgical procedure

AtriClip LAA Exclusion Device

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
Cardiac Disorder 3
General Disorder 1
Infections and Infestations 2
Neoplasms Benign (Carcinoid Tumor Pulmonary) 1
Respiratory Failure 1
6.Secondary Outcome
Title Overall Adverse Event Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients.
Arm/Group Title AtriClip LAA Exclusion Device
Hide Arm/Group Description:

AtriClip delivered via minimally invasive surgical procedure

AtriClip LAA Exclusion Device

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
Blood and Lymphatic System Disorders (Anaemia) 3
Cardiac Disorder 3
Eye Disorder (Cataract) 1
Gastrointestinal Disorder 3
General Disorder 3
Immune Disorder (Seasonal Allergy) 1
Infections and Infestations 5
Injury (Accident at Home, Radius Fracture) 2
Investigations 2
Metabolism and Nutrition Disorder 1
Neoplasms Benign (Carcinoid Tumor Pulmonary) 1
Nervous System Disorder 1
Psychiatric Disorder 1
Renal and Urinary Disorder 2
Respiratory Disorder 4
Surgical and Medical Procedure 1
Vascular Disorder 2
Time Frame Incidence of Serious Adverse Events reported during the study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AtriClip LAA Exclusion Device
Hide Arm/Group Description

AtriClip delivered via minimally invasive surgical procedure

AtriClip LAA Exclusion Device

All-Cause Mortality
AtriClip LAA Exclusion Device
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AtriClip LAA Exclusion Device
Affected / at Risk (%) # Events
Total   5/10 (50.00%)    
Cardiac disorders   
Atrial Fibrillation   2/10 (20.00%)  2
Sick sinus syndrome   1/10 (10.00%)  1
General disorders   
Chest pain   1/10 (10.00%)  1
Infections and infestations   
Pnemonia   1/10 (10.00%)  1
Respiratory Tract Infection   1/10 (10.00%)  1
Sepsis   1/10 (10.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Carinoid tumor pulmonary   1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory failure   1/10 (10.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AtriClip LAA Exclusion Device
Affected / at Risk (%) # Events
Total   8/10 (80.00%)    
Blood and lymphatic system disorders   
Anaemia   3/10 (30.00%)  3
Cardiac disorders   
Cardiovascular Deconditioning   3/10 (30.00%)  3
Diastolic Dysfunction   1/10 (10.00%)  1
Sick Sinus Sundrome   1/10 (10.00%)  1
Eye disorders   
Cataract   1/10 (10.00%)  1
Gastrointestinal disorders   
Ascites   1/10 (10.00%)  1
Constipation   1/10 (10.00%)  1
Haemorrhoids   1/10 (10.00%)  1
Rectal Haemorrhage   1/10 (10.00%)  1
General disorders   
Pyrexia   2/10 (20.00%)  2
Chest Pain   1/10 (10.00%)  1
Immune system disorders   
Seasonal Allergy   1/10 (10.00%)  1
Infections and infestations   
Bronchitis   1/10 (10.00%)  1
Pharyngitis   1/10 (10.00%)  1
Upper Respiratory Tract Infection   1/10 (10.00%)  1
Urinary Tract Infection   1/10 (10.00%)  1
Injury, poisoning and procedural complications   
Accident at Home   1/10 (10.00%)  1
Radius Fracture   1/10 (10.00%)  1
Investigations   
Biopsy Lung Abnormal   1/10 (10.00%)  1
Troponin Increased   1/10 (10.00%)  1
Metabolism and nutrition disorders   
Electrolyte Imbalance   1/10 (10.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Carinoid Tumor Pulmonary   1/10 (10.00%)  1
Nervous system disorders   
Syncope   1/10 (10.00%)  1
Pregnancy, puerperium and perinatal conditions   
Altered State of Consciousness   1/10 (10.00%)  1
Psychiatric disorders   
Anxiety   1/10 (10.00%)  1
Renal and urinary disorders   
Diabetic Nephropathy   1/10 (10.00%)  1
Oliguria   1/10 (10.00%)  1
Renal Colic   1/10 (10.00%)  1
Renal Failure   1/10 (10.00%)  1
Renal Failure Acute   1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Hypoxia   2/10 (20.00%)  2
Atelectasis   1/10 (10.00%)  1
Epistaxis   1/10 (10.00%)  1
Pulmonary Hypertension   1/10 (10.00%)  1
Respiratory Distress   1/10 (10.00%)  1
Respiatory Failure   1/10 (10.00%)  1
Surgical and medical procedures   
Cataract Operation   1/10 (10.00%)  1
Vascular disorders   
Haematoma   1/10 (10.00%)  1
Hypotension   1/10 (10.00%)  1
Thrombophlebitis   1/10 (10.00%)  1
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Basel Ramlawi, MD
Organization: Methodist Hospital Houston
Phone: 713-441-5200
Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT01997905     History of Changes
Other Study ID Numbers: CP2011-2
First Submitted: November 21, 2013
First Posted: November 28, 2013
Results First Submitted: January 27, 2016
Results First Posted: October 21, 2016
Last Update Posted: December 14, 2016