Back to resultsLeft Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial (LeAAPS)
Primary Purpose
Ischemic Stroke, Systemic Embolism
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AtriClip LAA Exclusion System
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- Subjects ≥ 18 years of age
Documentation of any of the following clinical criteria:
- CHA2DS2-VASc ≥ 4 with age ≥ 65
- CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP
- CHA2DS2-VASc = 3 with age ≥ 75
- CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP
- CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP
Exclusion Criteria:
Clinically significant atrial fibrillation or atrial flutter:
- Anytime in the past and
- Documented by an electrocardiographic recording and
- Episode lasting 6 minutes or longer1*
- Prior procedure involving opening the pericardium or entering the pericardial space
- Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
Planned cardiac surgical procedure using non-sternotomy approaches
o Partial sternotomies will be allowed.
- Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices
- Active endocarditis
- Active systemic infection at the time of cardiac surgery requiring antibiotics, including known SARS-CoV2 infections regardless of symptoms
- Known allergy to Nitinol or nickel sensitivity
- Known medical condition with expected survival of less than 1 year
- Other comorbidities that in the investigator's opinion make the subject unsuitable candidate to complete the protocol required visits.
- Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial.
- Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
- Pregnancy
- Known severe symptomatic carotid disease
Sites / Locations
- Heart Center Research / Huntsville HospitalRecruiting
- CHI St. VincentRecruiting
- Arkansas Heart HospitalRecruiting
- Keck Medical Center of USCRecruiting
- Hoag Memorial Hospital PresbyterianRecruiting
- Medstar Washington Hospital CenterRecruiting
- HealthPark Medical CenterRecruiting
- University of Florida HospitalRecruiting
- Orlando Regional Medical CenterRecruiting
- Sarasota Memorial HospitalRecruiting
- Baycare Health SystemRecruiting
- Piedmont HospitalRecruiting
- Wellstar - KennestoneRecruiting
- Northwestern Memorial HospitalRecruiting
- Loyola University Medical CenterRecruiting
- FranciscanRecruiting
- Mercy Medical CenterRecruiting
- University of Louisville Health / Jewish HospitalRecruiting
- Johns Hopkins HospitalRecruiting
- University of MichiganRecruiting
- Corewell HealthRecruiting
- Trinity Health (formerly St. Joesph Mercy)Recruiting
- Abbott Northwestern / Minneapolis HeartRecruiting
- Mayo ClinicRecruiting
- North Mississippi Medical CenterRecruiting
- Midwest Heart and Vascular (HCA)Recruiting
- Washington UniversityRecruiting
- North Shore University Hospital (Northwell)Recruiting
- St. Francis HospitalRecruiting
- St. Joseph HospitalRecruiting
- WakeMed Health & HospitalsRecruiting
- Christ Hospital / Lindner Research CenterRecruiting
- University Hospitals of ClevelandRecruiting
- Ohio State Medical CenterRecruiting
- The Toledo Hospital (Promedica)Recruiting
- Lancaster General HospitalRecruiting
- Allegheny General HospitalRecruiting
- UPMC Health SystemRecruiting
- Lankenau HospitalRecruiting
- Medical University of South Carolina (MUSC)Recruiting
- Jackson Madison County GeneralRecruiting
- Centennial Medical Center (TriStar)Recruiting
- Baylor Heart Hospital - PlanoRecruiting
- Trinity Mother Frances (CHRISTUS)Recruiting
- University of UtahRecruiting
- Sentara Hospitals & Sentara Medical GroupRecruiting
- West Virginia UniversityRecruiting
- Hamilton General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
No LAAE concomitant to and at the time of planned cardiac surgery
Outcomes
Primary Outcome Measures
Primary Effectiveness Endpoint
Time to the first occurrence of ischemic stroke or systemic arterial embolism as adjudicated by the Clinical Events Committee (CEC), or any procedure wherein the LAA was excluded, occluded, or amputated following the index procedure.
Primary Safety Endpoint
Occurrence of at least one of the following events assessed through 30 days post index procedure:
Pericardial effusion requiring percutaneous or surgical treatment
Major bleeding attributable to index surgical procedure
Deep sternal wound infection
Myocardial infarction
Secondary Outcome Measures
Powered Secondary Effectiveness endpoint
Time to the first occurrence of ischemic stroke or systemic arterial embolism
Full Information
NCT ID
NCT05478304
First Posted
July 15, 2022
Last Updated
September 18, 2023
Sponsor
AtriCure, Inc.
Collaborators
Population Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05478304
Brief Title
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Acronym
LeAAPS
Official Title
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
December 2031 (Anticipated)
Study Completion Date
April 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AtriCure, Inc.
Collaborators
Population Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Systemic Embolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
6500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
Arm Title
Control
Arm Type
No Intervention
Arm Description
No LAAE concomitant to and at the time of planned cardiac surgery
Intervention Type
Device
Intervention Name(s)
AtriClip LAA Exclusion System
Intervention Description
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint
Description
Time to the first occurrence of ischemic stroke or systemic arterial embolism as adjudicated by the Clinical Events Committee (CEC), or any procedure wherein the LAA was excluded, occluded, or amputated following the index procedure.
Time Frame
Common termination point (median follow-up for 5 years)
Title
Primary Safety Endpoint
Description
Occurrence of at least one of the following events assessed through 30 days post index procedure:
Pericardial effusion requiring percutaneous or surgical treatment
Major bleeding attributable to index surgical procedure
Deep sternal wound infection
Myocardial infarction
Time Frame
30 days post index procedure
Secondary Outcome Measure Information:
Title
Powered Secondary Effectiveness endpoint
Description
Time to the first occurrence of ischemic stroke or systemic arterial embolism
Time Frame
Common termination point (median follow-up for 5 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects ≥ 18 years of age
Documentation of any of the following clinical criteria:
CHA2DS2-VASc ≥ 4 with age ≥ 65
CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP
CHA2DS2-VASc = 3 with age ≥ 75
CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP
CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP
Exclusion Criteria:
Clinically significant atrial fibrillation or atrial flutter:
Anytime in the past and
Documented by an electrocardiographic recording and
Episode lasting 6 minutes or longer1*
Prior procedure involving opening the pericardium or entering the pericardial space
Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
Planned cardiac surgical procedure using non-sternotomy approaches
o Partial sternotomies will be allowed.
Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices
Active endocarditis
Active systemic infection at the time of cardiac surgery requiring antibiotics, including known SARS-CoV2 infections regardless of symptoms
Known allergy to Nitinol or nickel sensitivity
Known medical condition with expected survival of less than 1 year
Other comorbidities that in the investigator's opinion make the subject unsuitable candidate to complete the protocol required visits.
Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial.
Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
Pregnancy
Known severe symptomatic carotid disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirstin Smentek
Phone
612.430.1398
Email
ksmentek@atricure.com
First Name & Middle Initial & Last Name or Official Title & Degree
LeAAPS inbox
Email
LeAAPSTrial@atricure.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Whitlock, MD
Organizational Affiliation
McMaster University
Official's Role
Study Chair
Facility Information:
Facility Name
Heart Center Research / Huntsville Hospital
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina St. Germain
Phone
256-519-8203
Email
kstgermain@theheartcenter.md
First Name & Middle Initial & Last Name & Degree
Shaf Holden, MD
Facility Name
CHI St. Vincent
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Bass
Phone
501-552-8342
Email
Lynn.bass@commonspirit.org
First Name & Middle Initial & Last Name & Degree
Thomas Rayburn, MD
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leybi Ramirez-Kelly
Phone
501-519-3815
Email
leybi.ramirez-kelly@arheart.com
First Name & Middle Initial & Last Name & Degree
Kris Freeland, MD
Facility Name
Keck Medical Center of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Mullin
Phone
323-442-6226
Email
Stephanie.Mullin@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Praeger, MD
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gene Graham
Phone
949-964-4511
Email
gene.graham@hoag.org
First Name & Middle Initial & Last Name & Degree
Timothy Lee, MD
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Mahoney
Phone
202-877-2806
Email
Katherine.e.mahoney@medstar.net
First Name & Middle Initial & Last Name & Degree
Christian Shultz, MD
Facility Name
HealthPark Medical Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Deckard
Phone
317-979-7062
Email
michelle.deckard@leehealth.org
First Name & Middle Initial & Last Name & Degree
Paul DiGiorgi, MD
Facility Name
University of Florida Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Cobb
Phone
352-273-7837
Email
jessica.cobb@surgery.ufl.edu
First Name & Middle Initial & Last Name & Degree
Tom Beaver, MD
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin Cox
Phone
321-841-1505
Email
caitlin.cox@orlandohealth.com
First Name & Middle Initial & Last Name & Degree
Anthony J. Rongione, MD
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Lindner
Phone
941-993-9634
Email
colleen-lindner@smh.com
First Name & Middle Initial & Last Name & Degree
Jeffrey Sell, MD
Facility Name
Baycare Health System
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Herring
Phone
813-294-6574
Email
karen.herring@baycare.org
First Name & Middle Initial & Last Name & Degree
Andrew Sherman, MD
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caryn Bernstein
Phone
404-605-5688
Email
caryn.bernstein@piedmont.org
First Name & Middle Initial & Last Name & Degree
Vinod Thourani, MD
Facility Name
Wellstar - Kennestone
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Cuvo
Phone
770-590-4180
Email
jennifer.cuvo@Wellstar.org
First Name & Middle Initial & Last Name & Degree
Richard Myung, MD
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaysi Gray
Phone
312-926-2081
Email
kaysi.gray@nm.org
First Name & Middle Initial & Last Name & Degree
Patrick McCarthy, MD
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Klein
Phone
708-327-2761
Email
wklein@luc.edu
First Name & Middle Initial & Last Name & Degree
Chirantan Mangukia, MD
Facility Name
Franciscan
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan McCauley
Phone
317-893-1904
Email
Meghan.McCauley@franciscanalliance.org
First Name & Middle Initial & Last Name & Degree
Marc Gerdisch, MD
Facility Name
Mercy Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cayla Garner
Phone
515-235-5089
Email
Cayla.barnhart@commonspirit.org
First Name & Middle Initial & Last Name & Degree
Yuichi Ishida, MD
Facility Name
University of Louisville Health / Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terry Blanton
Phone
502-587-4381
Email
mary.blanton@louisville.edu
First Name & Middle Initial & Last Name & Degree
Mark Slaughter, MD
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zyriah Robinson
Phone
443-927-3983
Email
zyriah.robinson@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Michael P. Robich, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
China Green
Phone
734-936-7731
Email
chjgreen@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Matthew Romano, MD
Facility Name
Corewell Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Wittenbach
Phone
616-391-2066
Email
denise.wittenbach@spectrumhealth.org
First Name & Middle Initial & Last Name & Degree
Charles Willekes, MD
Facility Name
Trinity Health (formerly St. Joesph Mercy)
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Thompson
Phone
734-712-5451
Email
megan_thompson@michiganheart.com
First Name & Middle Initial & Last Name & Degree
Rob Lyons, MD
Facility Name
Abbott Northwestern / Minneapolis Heart
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Morley
Phone
612-863-6066
Email
pamela.morley@allina.com
First Name & Middle Initial & Last Name & Degree
Vinayak Bapat, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Osmundson
Phone
501-422-0339
Email
osmundson.kimberly@mayo.edu
First Name & Middle Initial & Last Name & Degree
Gabor Bagameri, MD
Facility Name
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adina Morgan
Phone
662-377-3000
Email
ammorgan@nmhs.net
First Name & Middle Initial & Last Name & Degree
David Talton, MD
Facility Name
Midwest Heart and Vascular (HCA)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Fulks
Phone
913-253-3022
Email
elizabeth.fulks@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Justin Van Meeteren, MD
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Hermeyer
Phone
636-383-1721
Email
jhermeyer@wustl.edu
First Name & Middle Initial & Last Name & Degree
Ralph Damiano, MD
Facility Name
North Shore University Hospital (Northwell)
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Effe Mihelis
Phone
662-377-5447
Email
emihelis@northwell.edu
First Name & Middle Initial & Last Name & Degree
Alan Hartman, MD
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Santiago
Phone
516-562-6763
Email
Lyn.santiago@chsli.org
First Name & Middle Initial & Last Name & Degree
Albert DiMeo, MD
Facility Name
St. Joseph Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Mowers
Phone
315-269-9090
Email
laura.mowers@sjhcardiology.org
First Name & Middle Initial & Last Name & Degree
Charles Lutz, MD
Facility Name
WakeMed Health & Hospitals
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rhonda Norton
Phone
919-369-6700
Email
rnorton@wakemed.org
First Name & Middle Initial & Last Name & Degree
Judson Williams, MN
Facility Name
Christ Hospital / Lindner Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Gloria
Phone
513-585-1777
Email
KatherineAubre.Glori@thechristhospital.com
First Name & Middle Initial & Last Name & Degree
J. Michael Smith, MD
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Mazzurco
Phone
216-844-3130
Email
Stacey.Mazzurco@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Izabella Saini
Email
Izabella.saini@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Greg Rushing, MD
Facility Name
Ohio State Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neha Mali
Phone
614-688-5506
Email
Neha.Mali@osumc.edu
First Name & Middle Initial & Last Name & Degree
Nahush Mokadam, MD
Facility Name
The Toledo Hospital (Promedica)
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lani Brighton
Phone
419-291-2373
Email
lani.brighton@promedica.org
First Name & Middle Initial & Last Name & Degree
Michael Moront, MD
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Rebuck
Phone
717-544-1402
Email
jill.rebuck2@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Jeremy McGarvey, MD
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy Spirk
Phone
412-359-4025
Email
tracy.spirk@ahn.org
First Name & Middle Initial & Last Name & Degree
Stephen Bailey, MD
Facility Name
UPMC Health System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Konopka (Valchar)
Phone
412-647-7271
Email
valcharka@upmc.edu
First Name & Middle Initial & Last Name & Degree
Ibrahim Sultan, MD
Facility Name
Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiraz Humayun
Phone
484-337-4365
Email
humayuns@mlhs.org
First Name & Middle Initial & Last Name & Degree
Basel Ramlawi, MD
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Schorr
Email
schorr@musc.edu
First Name & Middle Initial & Last Name & Degree
Marc Katz, MD
Facility Name
Jackson Madison County General
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Harris
Phone
731-541-6910
Email
mary.harris@wth.org
First Name & Middle Initial & Last Name & Degree
Eric Sievers, MD
Facility Name
Centennial Medical Center (TriStar)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cameron (Drew) Quillen
Phone
615-524-4021
Email
Cameron.Quillen@HCAhealthcare.com
First Name & Middle Initial & Last Name & Degree
Seenu Reddy, MD
Facility Name
Baylor Heart Hospital - Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elyza Guerrero
Email
Elyza.Guerrero@BSWHealth.org
First Name & Middle Initial & Last Name & Degree
Kelly Hutchensen, MD
Facility Name
Trinity Mother Frances (CHRISTUS)
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Baker
Phone
903-606-3536
Email
amanda.baker3@christushealth.org
First Name & Middle Initial & Last Name & Degree
James Caccitiolo, MD
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chalese Groberg
Phone
801-585-3752
Email
chalese.Groberg@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Vikas Sharma, MD
Facility Name
Sentara Hospitals & Sentara Medical Group
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linette Klevan
Phone
757-388-2425
Email
lrklevan@sentara.com
First Name & Middle Initial & Last Name & Degree
Christopher Sciortino, MD
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josh Bombard
Phone
304-598-6424
Email
josh.bombard@wvumedicine.org
First Name & Middle Initial & Last Name & Degree
James Mehaffey, MD
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Mullen
Phone
905-521-2100
Ext
44342
Email
courtney.mullen@phri.ca
First Name & Middle Initial & Last Name & Degree
Richard Whitlock, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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