Trial Outcomes & Findings for Stroke Feasibility Study (NCT NCT01997905)
NCT ID: NCT01997905
Last Updated: 2016-12-14
Results Overview
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).
COMPLETED
PHASE1/PHASE2
13 participants
30 days post-index procedure
2016-12-14
Participant Flow
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.
Participant milestones
| Measure |
AtriClip LAA Exclusion Device
AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
Baseline Completed
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stroke Feasibility Study
Baseline characteristics by cohort
| Measure |
AtriClip LAA Exclusion Device
n=11 Participants
AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
72 Years
STANDARD_DEVIATION 8.85 • n=5 Participants
|
|
Gender
Female
|
4 Participants
n=5 Participants
|
|
Gender
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
NYHA Functional Class
I (No symptoms and no limitations)
|
6 participants
n=5 Participants
|
|
NYHA Functional Class
II (Mild symptoms and slight limitation)
|
3 participants
n=5 Participants
|
|
NYHA Functional Class
III (Marked limitation)
|
0 participants
n=5 Participants
|
|
NYHA Functional Class
IV (Severe limitations)
|
0 participants
n=5 Participants
|
|
NYHA Functional Class
No Heart Block
|
1 participants
n=5 Participants
|
|
NYHA Functional Class
Not Reported
|
1 participants
n=5 Participants
|
|
CHADS2 Score
|
2.9 units on a scale
STANDARD_DEVIATION 0.88 • n=5 Participants
|
|
CHA2DSVAS Score
|
4.6 units on a scale
STANDARD_DEVIATION 0.84 • n=5 Participants
|
|
HAS-BLED Score
|
3.6 units on a scale
STANDARD_DEVIATION 0.70 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days post-index procedureThe 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).
Outcome measures
| Measure |
AtriClip LAA Exclusion Device
n=10 Participants
AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device
|
|---|---|
|
Number of Serious Adverse Events Within 30 Days Post-Index Procedure
|
0 participants
|
PRIMARY outcome
Timeframe: Immediate to 3-months post-index procedurePopulation: Ten (10) patients were treated, however the AtriClip® device was not implanted in one (1) patient.
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.
Outcome measures
| Measure |
AtriClip LAA Exclusion Device
n=9 Participants
AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device
|
|---|---|
|
Composite Left Atrial Appendage Placement and Exclusion Success
|
8 participants
|
SECONDARY outcome
Timeframe: 3 months and 6 months post-index procedureThe 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.
Outcome measures
| Measure |
AtriClip LAA Exclusion Device
n=10 Participants
AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device
|
|---|---|
|
Rate of Stroke and Non-CNS Systemic Embolism
|
0 participants
|
SECONDARY outcome
Timeframe: 3 month and 6 month post-index procedureOverall 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.
Outcome measures
| Measure |
AtriClip LAA Exclusion Device
n=10 Participants
AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device
|
|---|---|
|
Serious Device or Procedure Related Adverse Event Rate
|
0 participants
|
SECONDARY outcome
Timeframe: 3 month and 6 month Post Index ProcedurePopulation: All treated patients.
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.
Outcome measures
| Measure |
AtriClip LAA Exclusion Device
n=10 Participants
AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device
|
|---|---|
|
Overall Serious Adverse Event Rate
Cardiac Disorder
|
3 participants
|
|
Overall Serious Adverse Event Rate
General Disorder
|
1 participants
|
|
Overall Serious Adverse Event Rate
Infections and Infestations
|
2 participants
|
|
Overall Serious Adverse Event Rate
Neoplasms Benign (Carcinoid Tumor Pulmonary)
|
1 participants
|
|
Overall Serious Adverse Event Rate
Respiratory Failure
|
1 participants
|
SECONDARY outcome
Timeframe: 3 month and 6 month post-index procedurePopulation: All treated patients.
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.
Outcome measures
| Measure |
AtriClip LAA Exclusion Device
n=10 Participants
AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device
|
|---|---|
|
Overall Adverse Event Rate
Blood and Lymphatic System Disorders (Anaemia)
|
3 participants
|
|
Overall Adverse Event Rate
Cardiac Disorder
|
3 participants
|
|
Overall Adverse Event Rate
Eye Disorder (Cataract)
|
1 participants
|
|
Overall Adverse Event Rate
Gastrointestinal Disorder
|
3 participants
|
|
Overall Adverse Event Rate
General Disorder
|
3 participants
|
|
Overall Adverse Event Rate
Immune Disorder (Seasonal Allergy)
|
1 participants
|
|
Overall Adverse Event Rate
Infections and Infestations
|
5 participants
|
|
Overall Adverse Event Rate
Injury (Accident at Home, Radius Fracture)
|
2 participants
|
|
Overall Adverse Event Rate
Investigations
|
2 participants
|
|
Overall Adverse Event Rate
Metabolism and Nutrition Disorder
|
1 participants
|
|
Overall Adverse Event Rate
Neoplasms Benign (Carcinoid Tumor Pulmonary)
|
1 participants
|
|
Overall Adverse Event Rate
Nervous System Disorder
|
1 participants
|
|
Overall Adverse Event Rate
Psychiatric Disorder
|
1 participants
|
|
Overall Adverse Event Rate
Renal and Urinary Disorder
|
2 participants
|
|
Overall Adverse Event Rate
Respiratory Disorder
|
4 participants
|
|
Overall Adverse Event Rate
Surgical and Medical Procedure
|
1 participants
|
|
Overall Adverse Event Rate
Vascular Disorder
|
2 participants
|
Adverse Events
AtriClip LAA Exclusion Device
Serious adverse events
| Measure |
AtriClip LAA Exclusion Device
n=10 participants at risk
AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
20.0%
2/10 • Number of events 2 • Incidence of Serious Adverse Events reported during the study
|
|
Infections and infestations
Pnemonia
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Infections and infestations
Respiratory Tract Infection
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Cardiac disorders
Sick sinus syndrome
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
General disorders
Chest pain
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carinoid tumor pulmonary
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
Other adverse events
| Measure |
AtriClip LAA Exclusion Device
n=10 participants at risk
AtriClip delivered via minimally invasive surgical procedure
AtriClip LAA Exclusion Device
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
30.0%
3/10 • Number of events 3 • Incidence of Serious Adverse Events reported during the study
|
|
Cardiac disorders
Cardiovascular Deconditioning
|
30.0%
3/10 • Number of events 3 • Incidence of Serious Adverse Events reported during the study
|
|
Cardiac disorders
Diastolic Dysfunction
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Cardiac disorders
Sick Sinus Sundrome
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Eye disorders
Cataract
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Gastrointestinal disorders
Ascites
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
General disorders
Pyrexia
|
20.0%
2/10 • Number of events 2 • Incidence of Serious Adverse Events reported during the study
|
|
General disorders
Chest Pain
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Immune system disorders
Seasonal Allergy
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Infections and infestations
Pharyngitis
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Injury, poisoning and procedural complications
Accident at Home
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Investigations
Biopsy Lung Abnormal
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Investigations
Troponin Increased
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carinoid Tumor Pulmonary
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Pregnancy, puerperium and perinatal conditions
Altered State of Consciousness
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Renal and urinary disorders
Diabetic Nephropathy
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Renal and urinary disorders
Oliguria
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Renal and urinary disorders
Renal Colic
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Renal and urinary disorders
Renal Failure
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Renal and urinary disorders
Renal Failure Acute
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
2/10 • Number of events 2 • Incidence of Serious Adverse Events reported during the study
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Respiratory, thoracic and mediastinal disorders
Respiatory Failure
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Surgical and medical procedures
Cataract Operation
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Vascular disorders
Haematoma
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
|
Vascular disorders
Thrombophlebitis
|
10.0%
1/10 • Number of events 1 • Incidence of Serious Adverse Events reported during the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place