Left Atrial Appendage Closure With SentreHeart Lariat® Device
Phase: NA
Conditions: Cardioembolic Stroke, Atrial Fibrillation
Sponsor: Baylor Research Institute

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Protocol Version: #2 NCT02681042 
Date: June 8, 2015 
 
 
PROTOCOL 
 
 
STUDY TITLE:  
Left Atrial Appendage Closure with SentreHeart Lariat® Device  
 
 
 
SITE LOCATION: 
The Heart Hospital Baylor Plano 
 
 
 
1100 Allied Drive, Suite 5-236 
 
 
 
Plano, TX  75093 
 
ADDITIONAL SITES: 
Baylor Jack and Jane Hamilton Heart and Vascular Hospital 
 
 
 
621 North Hall Street 
 
 
 
Dallas, TX  75226 
 
 
 
 
Baylor All Saints Medical Center 
 
 
 
1400 8th Ave 
Fort Worth, TX 76104 
 
 
 
 
Baylor Scott & White Memorial Hospital 
 
 
 
2401 South 31st Street 
 
 
 
Temple, TX  76508 
 
Principal Investigator: J. Brian DeVille, M.D. 
 
Sub-Investigators: 
 
Kevin Wheelan, MD 
 
 
 
 
Robert Kowal, MD 
 
 
 
 
Michael Delaughter, MD 
Javier Banchs, MD 
 
 
 
 
 
 
 
 
 

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1. BACKGROUND & STUDY RATIONALE 
 
Left atrial appendage and stroke 
Stroke, particularly cardioembolic stroke, is a frequent and serious complication of atrial 
fibrillation.  Previous reports have shown that the left atrial appendage (LAA) is the source 
of embolus in the majority of patients who suffer this complication. 
 
Traditionally, oral anticoagulant medications (OAC) have been used to reduce the risk of 
embolic stroke in patients with atrial fibrillation.  Warfarin has been the most frequently 
used agent in this regard.  Recently dabigatran, rivaroxaban, and apixaban have been 
introduced for the same purpose.  These novel agents have potential advantages over 
warfarin; they are less susceptible to dietary and drug-drug interactions.  Due to their 
mechanism of action, routine INR testing is not necessary.  For these reasons, their use is 
increasing, and many physicians report increased compliance with anticoagulation with the 
newer regimens.  However, there is a significant patient population who continue to be at 
elevated bleeding risk with the use of any OAC.  Patients with clinically significant bleeding, 
intracranial hemorrhage, and patients with a prohibitively high risk of falls often do not 
receive OAC therapy, and remain at elevated risk for stroke. 
 
Left atrial appendage management 
There are at the present three methods of addressing management of the LAA aside from 
oral anticoagulant therapy:  Surgical excision, external ligation of the appendage, and 
internal occlusion of the left atrial appendage. 
 
Surgical excision is generally performed during a concomitant cardiac procedure. The 
proximal portion of the appendage is closed with sutures or staples, and the trabeculated 
portion is removed.  This has been shown to reduce risk of stroke after cardiac surgery.  
Surgeons note that this can result in significant bleeding, and other alternatives have 
recently been employed. 
 
Internal occlusion is accomplished via a transseptal approach. The Watchman® device 
(Boston Scientific, Inc.) has completed its second controlled trial. The results of the 
PROTECT-AF trial were presented at the Heart Rhythm Society Scientific Sessions in Denver, 
CO on May 9, 2013, and seemed to show non-inferiority, and in some endpoints, superiority 
to, medical therapy with warfarin.  The Amplatzer Cardiac Plug® trial was discontinued by 
the sponsor, and no public announcement has been made regarding restarting the trial.  For 
both of these devices, OAC therapy is required for at least 45 days post-procedure. OAC 
therapy is required for a greater period of time if LAA closure is incomplete. 
 

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Two devices have been used in multiple centers in the US for ligation of the LAA, the 
AtriClip® (AtriCure, Inc) and the SentreHeart Lariat® (SentreHeart, Inc).  The AtriClip® is a 
surgical device approved for LAA closure in patients undergoing other cardiac procedures.  
Deployment of the AtriClip® has not received an FDA indication as a stand-alone procedure. 
The Lariat® device is approved for soft tissue ligation, without a specific indication for LAA 
closure.   
 
2. STUDY OBJECTIVES 
 
Objectives 
1. The primary aim is to assess the outcome of patients undergoing left atrial appendage 
ligation or closure with the SentreHeart Lariat® device as a stand-alone procedure at the 
participating centers 
2. Secondary aims include assessment of adverse events and successful LAA closure rates  
 
Hypothesis 
Closure of the left atrial appendage with the SentreHeart Lariat® is reasonable alternative to 
reduce the risk of stroke in patients with an elevated bleeding risk with the use of any OAC 
and in whom this risk is prohibitive. 
 
3. STUDY DESIGN 
The study is a multi-center, prospective outcomes registry. The study cohort will comprise 
all consecutive patients who undergo lone left atrial appendage closure using the 
SentreHeart Lariat® at the investigational centers and should consist of up to 50 patients.  
Patients will undergo follow-up visits at 7 days, 90 days, and 180 days post procedure.  
 
4. STUDY POPULATION 
The study cohort will consist of up to 50 patients who are candidates for LAA closure in 
whom oral anticoagulation is contraindicated. 
4.1 Inclusion Criteria 
 Patients aged ≥18 years 
 Patients able and willing to provide informed consent 
 Documentation of atrial fibrillation or atrial flutter  
 Clinical decision by the subject’s physician that the patient is at risk for embolic 
stroke, and OAC is contraindicated (using the assessment outlined in Table 1) 
 HAS-BLED score > 3 
 CHADS2-VASC score >3, OR CHADS2-VASC of 2 if physician provides justification for 
procedure 
 Anatomy favorable for deployment of the SentreHeart Lariat® 

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4.2 Exclusion Criteria 
 Medically unable to provide informed consent 
 Previous cardiothoracic surgery 
 Patient is a candidate for catheter or surgical ablation 
 Need for concomitant cardiac surgery procedure 
 Thrombus in the left atrial appendage or left atrium 
 Pregnancy  
 
4.3 Inclusion of special, vulnerable or high risk populations  
4.3.1 Elderly 
Atrial fibrillation and atrial flutter are most common in the aging population and 
would account for the inclusion of this population. Ample time will be allotted to 
assure that this population has the opportunity to carefully read the consent, share 
this information with family members, and discuss the objective of the study along 
with any risks/benefits that may be expected.   Subjects will have all of their 
questions answered before signing the consent and taking part in the study. 
 
5.  ENROLLMENT & STUDY PROCEDURES 
Subjects evaluated for left atrial appendage closure will be screened for inclusion and 
consented prior to their procedure.  During clinical evaluation of the patient, the physician 
investigator will assess those items described in Table 1. If the anatomy is favorable for 
placement of the Lariat® device, the procedure will be performed at one of the participating 
centers.  If anatomy is not favorable, the patient will be excluded from the study and 
managed using best care practices by his or her physician.  Please note, at The Heart Hospital 
Baylor Plano, the Lariat device is only available to patients participating in the study. 
 
Subjects consented will be tracked by the study team and will be considered enrolled in this 
study at the time of the start of their left atrial appendage closure procedure. All subjects 
that are consented who do not undergo left atrial appendage closure with SentreHeart 
Lariat® will be considered screen failures. Any patients that have a failed attempt at left 
atrial appendage closure with SentreHeart Lariat® will be tracked through their index 
hospitalization for safety; their study follow up will be complete at the time of discharge.  
 
The invasive procedure for placement of the study devices will proceed according to 
standard interventional techniques, as already in place at the participating centers.  Patients 
undergoing the Lariat® procedure will be administered colchicine 0.6 mg po twice daily for 
a minimum of three days preoperatively, and 30 days postoperatively.  (This dose may be 
adjusted for renal function or intolerance). 
 
 
 
 

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5.1 Baseline  
The following information will be collected for all subjects enrolled: 
1. History and Physical 
2. Cardiac medication list 
3. Labs: Creatinine, BUN 
4. CHADS2-VASC score 
5. HAS-BLED 
6. All females of childbearing age will have a urine or serum pregnancy test within 
24 hours prior to procedure 
7. Cardiac computed tomography angiography (CCTA) will be used to evaluate if 
subjects’ anatomy is favorable for deployment of the SentreHeart Lariat® 
 
5.2 Left Atrial Appendage Closure Procedure 
The following information will be collected at the time of Procedure 
1. 
TEE evidence of LAA closure  
2. 
Angiographic confirmation of LAA closure 
3. 
Presence/absence of pericardial effusion 
4. 
Amount (# ml) of pericardial drainage 
5. 
X-ray exposure 
6. 
Total amount of contrast used 
7. 
Adverse Events Ass 
8. 
essment 
 
5.3 Follow-up Visits 
 
5.3.1 7 days Post Procedure(-3/+10) 
1. Interim history and physical examination 
2. Cardiac Medications 
3. Chest X-Ray 
 
5.3.2  90 days post procedure (-15/+15) 
1. Interim history and physical examination 
2. Cardiac Medications 
3. Chest X-Ray 
 
5.3.3 180 days Post Procedure (-30/+30) 
1. Interim history and physical examination 
2. Cardiac Medications 
3. Chest X-Ray 

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4. Either Cardiac computed tomography angiography (CCTA) or 
Transesophagel Echocardiogram (TEE) to be completed to confirm 
LAA closure 
 
6. MATRIX       
  
Screening 
/Baseline 
Procedure 
7 Day 
Follow-up   
(-3/+10) 
90 Day 
Follow-up   
(-15/+15) 
180 Day 
Follow-up   
(-30/+30) 
History & Physical 
X 
  
  
  
  
EP Consultation 
X 
  
  
  
  
Cardiac Medication 
X 
  
X 
X 
X 
Labs: Creatinine & BUN 
X 
  
  
  
  
CHADS2-VASC Score 
X 
  
  
  
  
HAS-BLED Score 
X 
  
  
  
  
Chest X-Ray 
  
X 
X 
X 
TEE 
  
X 
  
  
X* 
CCTA 
X 
  
  
  
X* 
Angiography 
  
X 
  
  
  
Adverse Events Assessment
  
X 
X 
X 
X 
*Either a CCTA or TEE will be completed to confirm LAA 
closure
 
 
7. SUMMARY 
 
7.3.1 Enrollment:  up to 50 subjects to be enrolled  
 
7.3.2 Duration of Enrollment:  180 days (-30/+30) 
 
8. SCREENING 
Subjects evaluated for left atrial appendage closure will be screened for inclusion and 
consented prior to their procedure.  During clinical evaluation of the patient, the 
physician investigator will assess those items described in Table 1. If the anatomy is 
favorable for placement of the Lariat® device, the procedure will be performed at one of 
the participating centers.  If anatomy is not favorable, the patient will be excluded from 
the study and managed using best care practices by his or her physician. 
 

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A copy of the consent form will be given to the patient and another copy will be placed in 
the patients chart along with documentation of the consent process.  
 
 
9. ENROLLMENT 
 
Subjects consented will be tracked by the study team and will be considered enrolled in this 
study at the time of the start of their left atrial appendage closure procedure. All subjects that 
are consented who do not undergo left atrial appendage closure with SentreHeart Lariat® will 
be considered screen failures. Any patients that have a failed attempt at left atrial appendage 
closure with SentreHeart Lariat® will be tracked through their index hospitalization for safety; 
their study follow up will be complete at the time of discharge.  
 
Subjects that are approached will be given ample time to assure that this population has the 
opportunity to carefully read the consent, share the information with family members, and 
discuss the objective of the study along with any risks/benefits that may be expected. Subjects 
will have all of their questions answered before signing the consent and taking part in the study. 
Additionally, information on how to contact the study doctor will be provided in the consent 
form.  
 
9.3 Screening/Enrollment Log 
A log will be maintained that documents subjects screened and those enrolled. 
 
10. WITHDRAWAL 
A subject may voluntarily withdraw at any time. 
 
11. END OF STUDY 
Enrollment in this study will be completed once a subject completes all of the protocol required 
90 day assessments. If a subject is unable to complete these assessments, their enrollment will 
be completed at the end of the 90 day window unless an appointment has been made to 
complete an out of window visit for extenuating circumstances.  Any patients that have a failed 
attempt at left atrial appendage closure with SentreHeart Lariat® will be tracked through their 
index hospitalization for safety; their study follow up will be complete at the time of discharge.  
  
If unsuccessful attempts have been documented to contact and arrange an end of study follow-
up visit (90 day), the social security death index will be queried at a later date to confirm the 
subjects’ status at the time of study completion.  
 

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12. RISKS/BENEFIT 
12.1 Risks and Adverse Event Reporting 
The study is a multi-center, prospective outcomes registry. Adverse events will be reviewed, 
adjudicated and reported per IRB policy 
 
 
Known risks associated with the SentreHeart Lariat® procedure: 
- 
Pericardial Effusion 
- 
Cardiac Tamponade 
- 
Device Embolization 
- 
Atrioventricular Fistula 
- 
Cardiac Perforation 
- 
Thrombus 
- 
Bleeding 
- 
Bruising/Hematoma 
- 
Arrhythmia 
- 
Pseudoaneurysm 
- 
Valvular Damage 
- 
Stroke 
- 
Conversion to Surgery 
- 
Death 
 
12.2 Minimization of Risks 
Patient safety during this study will be the highest priority. The patients will not incur any 
psychological, social, legal or economic risks by participating in this study.  
12.3 Benefits 
Left atrial appendage closure with the use of SentreHeart Lariat® may reduce subjects’ risk of 
stroke. Information learned from this study may help in the management of patients with 
atrial fibrillation and atrial flutter who are at elevated bleeding risk with the use of any OAC 
therapy. 
 
13 DATA MANAGEMENT  
13.1 
Data Storage: 
An appropriate database will be created and managed in compliance with HIPAA regulations.  
Data will be stored safely in a secure environment, and maintenance for back-up purposes will 
be performed on a routine basis to avoid data loss. 
 

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13.2 Research Subject Privacy 
Patients will be approached discretely and privately by the study coordinator.  The discretion 
of the study coordinator will be used to judge if privacy (from both medical personnel and 
other persons in the hospital) is ensured during the consent process.  The patient will be 
informed that they can stop the consent process at any time if they feel their privacy is being 
compromised, and no information will be collected directly from the patient after that point.  
Patients will be informed that participating / not participating in this study will in no way 
affect their care and that they are in no way obligated or expected to participate.  If the 
patient agrees to participate, they will be taken through the informed consent process.  Upon 
data collection/acquisition, study identifiers will be encrypted to protect patients’ privacy 
and meet HIPAA regulations, and data will be stored in a secured database while periodic 
back-up. All hard copy material (summary printouts) will be stored securely and all 
electronic storage media will be safely stored as per HIPAA regulations. All patient identifiers 
will be removed from research related documents and a study specific identifier assigned to 
each subject. Only de-identified data will be used for analysis and only aggregate results will 
be reported. Only those directly related to the research will be allowed access to subject 
information.  
 
14 DATA MONITORING 
Internal monitoring will be conducted periodically and reviewed by the data monitoring committee. 
CRFs, source documents, informed consent forms, and study deviations will be included; these 
findings will be reported to the PI. Deviations will be documented and reported according to IRB 
policy. 
 
Regulatory documents will be audited by the Baylor Research Institute Department of Research 
Compliance upon request. 
 
15 STATISTICAL ANALYSIS & DATA MANAGEMENT 
Data on the clinical and non-clinical risk factors will be summarized using means, standard 
deviations (SDs) and percentages. Successful left atrial appendage closure will be reported as a 
percentage 
 
 

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Table 1.  Patient screening tool 
1. 
Atrial fibrillation or atrial flutter documented? 
 Yes  
 No 
 Paroxysmal 
 
 Short-lasting persistent 
 Longstanding persistent 
 
2. 
EP consultation to exclude candidacy for ablation? Yes  
No 
 
catheter  
or  
surgical 
 
3. 
CTA obtained to assess LAA anatomy? 
 Yes  
 No                                                                           
 
If yes, was anatomy favorable for this procedure?    Yes  
 No 
 
If no, justification for procedure: 
 
_________________________________________________________________________________________________________ 
 
If no, was second opinion obtained? 
 
 
 Yes  
 No 
 
Physician rendering second opinion:___________________________________________ 
 
4. 
CHADS2-VASC score 
 
_____of 9 
a.  CHF 
 
 
_____of 1 
b.  Hypertension 
 
_____of 1 
c.  Age >65 yrs 
 
_____of 1 
d.  Diabetes Mellitus 
_____of 1 
e.  Stroke or TIA 
  
_____of 2 
f.  
Vascular Disease 
_____of 1 
g.  Age >75  
 
_____of 1 (in addition to age>65) 
h.  Sex Category 
 
_____of 1 (Male=0; Female =1) 
 
5. CHADS2 score: 
 
 
_____of 6  
 
 
a. 
CHF 
 
 
_____of 1 
b. Hypertension 
 
_____of 1 
c. 
Age >75 yrs 
 
_____of 1 
d. Diabetes Mellitus 
_____of 1 
e. 
Stroke or TIA 
  
_____of 2 
 
6. HAS-BLED SCORE  
 
_____of 9 
a. 
Hypertension 
 
 
 
_____1 
b. Abnormal renal and hepatic function 2 
_____1-2 
c. 
Stroke  
 
 
 
_____1 
d. Bleeding tendency/predisposition3 
_____1 
e. 
Labile INRs on warfarin4  
 
_____1 
1Systolic BP >160 mmHg
2Renal:  serum creatinine >2.25 mg/dl 
  Hepatic:  Bili 2-3x normal and 
AST/ALT/ALK-P >3x normal or chronic 
disease (cirrhosis) 
3History of bleeding or anemia 
4Time in therapeutic range <60% 
5Concomitant antiplatelet or NSAID use or 
excess alcohol

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f. 
Elderly (>65 yr)  
 
 
_____1 
g. 
Drugs or alcohol (1 point each)5  
_____1-2 
 
6. 
If CHADS2–VASC score<3, or if HAS-BLED score is <3, list justification for procedure: 
______________________________________________________________________________________________________________
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