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Evaluation of Automatic Threshold Algorithms (CAPTIVATE)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRT-D
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Threshold algorithms, CRT-D

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects prescribed a CRT-D and indicated per guidelines, who will receive an AUTOGEN CRT-D model G160, G161, G172, G173
  2. Subjects who have an implanted functional endocardial right ventricular defibrillation lead or who will receive a endocardial right ventricular defibrillation lead
  3. Subjects who have an implanted functional bipolar or unipolar left ventricular lead or who will receive a bipolar or unipolar left ventricular lead
  4. Subjects who are willing and capable of providing informed consent to undergo a device implant procedure, and to participate in all testing and follow-ups defined in this protocol
  5. Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law

Exclusion Criteria:

  1. Subjects who have an implanted multipolar (>2poles) left ventricular lead or who will receive a multipolar (>2poles) left ventricular lead
  2. Subjects with an unknown model/manufacturer, or implant date for the RA, RV or LV lead
  3. Subjects for whom a RV defibrillation lead manufactured by St. Jude Medical or Biotronik is implanted, is planned to be implanted, or has been abandoned
  4. Implanted with an active Medtronic Sprint Fidelis® lead models: 6930, 6931, 6948 or 6949
  5. Subjects with an implanted or abandoned St. Jude Medical QuickSite® or QuickFlex® lead models: 1056T, 1058T, 1156T, 1158T
  6. Subjects with a RV or LV lead revision or extraction within 30 days of enrollment
  7. Subjects with an implanted lead that is planned to be extracted during the study implant procedure
  8. Subjects with an active implanted RA or RV lead that is greater than 10 years old, unless the lead will be abandoned
  9. Subjects with an active implanted LV lead that is greater than 8 years old, unless the lead will be abandoned
  10. Subjects preexisting unipolar pacemaker that will not be explanted/abandoned
  11. Subjects with a life expectancy less than 6 months
  12. Subjects with a prosthetic mechanical tricuspid heart valve
  13. Women of childbearing age who are pregnant or plan to become pregnant. NOTE: women of childbearing potential with an uncertain pregnancy status must have a negative pregnancy test within 7 days prior to enrollment. Pregnancy tests are required as part of standard routing clinical practice at all centers whenever female patients are exposed to x-ray radiation. Since this protocol does not require any exposure of the female patients to x-ray and x-ray exposure is part of the clinical procedure, it is the responsibility of the investigators to ensure that pregnant females will not be exposed to x-ray at any time
  14. Subject enrolled in a concurrent study, except national/governmental registries that do not require a signed informed consent form, without the written approval from Boston Scientific
  15. Subjects who are not geographically stable, to the extent that it would prevent attending the study follow-ups at the investigational center

Sites / Locations

  • Glendale Adventist Medical Center
  • Danbury Hospital
  • Washington Hospital Center
  • Delray Medical Center
  • St. Vincent's Medical Center
  • Baptist Medical Center
  • First Coast Cardiovascular
  • Orlando Regional Medical Center
  • University Community Hospital
  • Winter Haven Hospital
  • Carle Foundation Hospital
  • IU Health LaPorte
  • St. Luke's Hospital
  • University of Iowa Hospitals and Clinics
  • Via-Christi Regional Medical Center
  • Norton Cardiovascular Associates
  • University of Maryland Medical System
  • Steward St. Elizabeth's Medical Center of Boston, Inc.
  • St. John Hospital & Medical Center
  • Sparrow Health System
  • North Mississippi Medical Center
  • Cox Health
  • St. Patrick Hospital
  • Rochester General Hospital
  • Wake Medical Center
  • Summa Health System
  • Lindner Center for Research and Education
  • St. Elizabeth Health Center
  • Good Samaritan Hospital
  • University Medical Center-Greenville Memorial Hospital
  • Seton Medical Center
  • Cardiology Clinic of San Antonio
  • University of Utah Hospital and Clinics
  • Virginia Commonwealth University Health
  • PeaceHealth Southwest Medical
  • St. Mary's Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CRT-D

Arm Description

For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated

Outcomes

Primary Outcome Measures

Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate
Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead.
The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: |commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.
The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.
The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits.The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by:|Ambulatory threshold - ECG threshold| ≤ 0.6 V; if the ECG threshold is ≤ 3.5V or |Ambulatory threshold - ECG threshold| ≤ 1.0 V; if the ECG threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.
The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by: |Ambulatory threshold - ECG threshold| ≤ 1.0 V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.

Secondary Outcome Measures

RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome
This endpoint will evaluate the percent of RVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test: A device-determined threshold A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the RVAT feature and might not occur in manual threshold tests An appropriate RVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests. An inappropriate RVAT outcome consists of the last of the three outcomes listed above.
LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome
This endpoint will evaluate the percent of LVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test: A device-determined threshold A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the LVAT feature and might not occur in manual threshold tests An appropriate LVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests. An inappropriate LVAT outcome consists of the last of the three outcomes listed above.

Full Information

First Posted
March 20, 2014
Last Updated
April 17, 2018
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02097290
Brief Title
Evaluation of Automatic Threshold Algorithms
Acronym
CAPTIVATE
Official Title
CAPTure Information Via Automatic Threshold Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features for AUTOGEN Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices.
Detailed Description
The objective of the CAPTIVATE Clinical Study is to gather data to establish the safety and effectiveness of the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features to support the regulatory approval of the AUTOGEN CRT-D family of devices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Threshold algorithms, CRT-D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT-D
Arm Type
Experimental
Arm Description
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
Intervention Type
Device
Intervention Name(s)
CRT-D
Intervention Description
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
Primary Outcome Measure Information:
Title
Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate
Description
Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead.
Time Frame
3 months
Title
The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
Description
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: |commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.
Time Frame
1-month and 3-month follow-up visits
Title
The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
Description
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.
Time Frame
1-month and 3-month follow up visits
Title
The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
Description
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits.The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by:|Ambulatory threshold - ECG threshold| ≤ 0.6 V; if the ECG threshold is ≤ 3.5V or |Ambulatory threshold - ECG threshold| ≤ 1.0 V; if the ECG threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.
Time Frame
1-month and 3-month follow up visits
Title
The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
Description
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by: |Ambulatory threshold - ECG threshold| ≤ 1.0 V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.
Time Frame
1-month and 3-month follow up visits
Secondary Outcome Measure Information:
Title
RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome
Description
This endpoint will evaluate the percent of RVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test: A device-determined threshold A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the RVAT feature and might not occur in manual threshold tests An appropriate RVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests. An inappropriate RVAT outcome consists of the last of the three outcomes listed above.
Time Frame
3-month follow up visit
Title
LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome
Description
This endpoint will evaluate the percent of LVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test: A device-determined threshold A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the LVAT feature and might not occur in manual threshold tests An appropriate LVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests. An inappropriate LVAT outcome consists of the last of the three outcomes listed above.
Time Frame
3-month follow up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects prescribed a CRT-D and indicated per guidelines, who will receive an AUTOGEN CRT-D model G160, G161, G172, G173 Subjects who have an implanted functional endocardial right ventricular defibrillation lead or who will receive a endocardial right ventricular defibrillation lead Subjects who have an implanted functional bipolar or unipolar left ventricular lead or who will receive a bipolar or unipolar left ventricular lead Subjects who are willing and capable of providing informed consent to undergo a device implant procedure, and to participate in all testing and follow-ups defined in this protocol Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law Exclusion Criteria: Subjects who have an implanted multipolar (>2poles) left ventricular lead or who will receive a multipolar (>2poles) left ventricular lead Subjects with an unknown model/manufacturer, or implant date for the RA, RV or LV lead Subjects for whom a RV defibrillation lead manufactured by St. Jude Medical or Biotronik is implanted, is planned to be implanted, or has been abandoned Implanted with an active Medtronic Sprint Fidelis® lead models: 6930, 6931, 6948 or 6949 Subjects with an implanted or abandoned St. Jude Medical QuickSite® or QuickFlex® lead models: 1056T, 1058T, 1156T, 1158T Subjects with a RV or LV lead revision or extraction within 30 days of enrollment Subjects with an implanted lead that is planned to be extracted during the study implant procedure Subjects with an active implanted RA or RV lead that is greater than 10 years old, unless the lead will be abandoned Subjects with an active implanted LV lead that is greater than 8 years old, unless the lead will be abandoned Subjects preexisting unipolar pacemaker that will not be explanted/abandoned Subjects with a life expectancy less than 6 months Subjects with a prosthetic mechanical tricuspid heart valve Women of childbearing age who are pregnant or plan to become pregnant. NOTE: women of childbearing potential with an uncertain pregnancy status must have a negative pregnancy test within 7 days prior to enrollment. Pregnancy tests are required as part of standard routing clinical practice at all centers whenever female patients are exposed to x-ray radiation. Since this protocol does not require any exposure of the female patients to x-ray and x-ray exposure is part of the clinical procedure, it is the responsibility of the investigators to ensure that pregnant females will not be exposed to x-ray at any time Subject enrolled in a concurrent study, except national/governmental registries that do not require a signed informed consent form, without the written approval from Boston Scientific Subjects who are not geographically stable, to the extent that it would prevent attending the study follow-ups at the investigational center
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Ellenbogen, MD
Organizational Affiliation
Virginia Commonwealth University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glendale Adventist Medical Center
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Danbury Hospital
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Delray Medical Center
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
St. Vincent's Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Baptist Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
First Coast Cardiovascular
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University Community Hospital
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Winter Haven Hospital
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33881
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
IU Health LaPorte
City
LaPorte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
St. Luke's Hospital
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52043
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Via-Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Norton Cardiovascular Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
University of Maryland Medical System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Steward St. Elizabeth's Medical Center of Boston, Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
St. John Hospital & Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Sparrow Health System
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Cox Health
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
St. Patrick Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Wake Medical Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44034
Country
United States
Facility Name
Lindner Center for Research and Education
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
St. Elizabeth Health Center
City
Poland
State/Province
Ohio
ZIP/Postal Code
44514
Country
United States
Facility Name
Good Samaritan Hospital
City
Lebanon
State/Province
Pennsylvania
ZIP/Postal Code
17042
Country
United States
Facility Name
University Medical Center-Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Seton Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Cardiology Clinic of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah Hospital and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Virginia Commonwealth University Health
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
PeaceHealth Southwest Medical
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
St. Mary's Medical Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25702
Country
United States

12. IPD Sharing Statement

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Evaluation of Automatic Threshold Algorithms

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