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Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918) (SMARTMSP)

Primary Purpose

Left Ventricular Dysfunction

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 other trial for Left Ventricular Dysfunction focused on measuring Pacing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subjects who received de novo implantation of BSC's Resonate family of CRT-D devices with the LV MSP feature4 and BSC's ACUITYTM X4 LV Quadripolar leads. A Resonate family of CRT-D device upgrade from previous single or dual chamber pacemaker or ICD implantation is allowed.
  2. Subjects must meet BSC labeled indication for CRT-D implantation.
  3. Subjects must have a functional RA lead and RV lead implanted
  4. Subjects who are willing and capable of providing informed consent
  5. Subjects who are willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
  6. Subjects who are age 18 and above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

  1. Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system implantation.
  2. Subjects who received the LV MSP therapy post CRT-D implantation but prior to enrollment
  3. Subjects with documented history of permanent AF
  4. Subjects with documented permanent complete AV block
  5. Subjects who are expected to receive a heart transplant during the 12 months course of the study
  6. Subjects with documented life expectancy of less than 12 months
  7. Subjects who enrolled in any other concurrent study or registry, with the exception of mandatory national or governmental registry, without prior written approval from BSC

Sites / Locations

  • Mobile Infirmary Medical Center
  • Phoenix Cardiovascular Group
  • Cardiology Associates of NEA
  • Foothill Cardiology Medical Group
  • Chula Vista Cardiac Center
  • Kaiser Permanente Los Angeles Medical Center
  • Desert Heart Rhythm Consultants
  • Cardiology Associates Medical Group
  • Yale University School of Medicine
  • Delray Medical Center
  • UF Health Jacksonville
  • Florida Hospital Waterman
  • Tallahassee Research Institute
  • Augusta University
  • Alexian Brothers Hospital Network
  • Carle Foundation Hospital
  • Parkview Hospital Inc
  • University of Kansas Medical Center
  • Norton Heart Specialist
  • Advanced Cardiovascular Specialists
  • MedStar Heart and Vascular Institute
  • Beth Israel Deaconess Medical Center
  • Ascension St. John Hospital & Medical Center
  • Genesys Regional Medical Center
  • St. Mary's of Michigan Research Institute at Covenant Medical Ceter
  • UMMC- Division of Cardiology
  • St. Lukes Hospital
  • Billings Clinic
  • Methodist Physicians Clinic Heart Consultants
  • Deborah Heart and Lung Center
  • Hackensack University Medical Canter
  • Montefiore Medical Center
  • Durham VA medical Center
  • WakeMed
  • Trihealth- Good Samaritan & Bethesda North Hospitals
  • The Ohio State University Wexner Medical Center
  • St. Elizabeth Youngstown Hospital
  • Salem Health
  • Penn Presbyterian Medical Center
  • UPMC Presbyterian
  • Pinnacle Health Cardiovascular Institute
  • Berk Cardiologists
  • AnMed Health Clinical Research
  • Rapid City Regional Health
  • Stern Cardiovascular Foundation
  • Vanderbilt University Medical Center
  • Heartplace, PA
  • Brooke Army Medical Center
  • UT Health
  • University of Utah
  • University of Virginia
  • Carient Heart and Vascular
  • Sentara Norfolk General
  • St. Mary's Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.

Outcomes

Primary Outcome Measures

LV MSP Feature Related Complication-Free Rate
Proportion of subjects free from LVMSP feature related complications at 12 months
Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months
Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months.

Secondary Outcome Measures

Full Information

First Posted
August 18, 2017
Last Updated
December 7, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03257436
Brief Title
Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)
Acronym
SMARTMSP
Official Title
Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 5, 2018 (Actual)
Primary Completion Date
November 19, 2020 (Actual)
Study Completion Date
November 19, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prospective, multi-center, single arm, post approval study to be conducted in the United States.
Detailed Description
Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite Pacing) feature in the Resonate family of CRT-D devices and confirm safety in a post approval study when used in accordance with its approved labeling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Dysfunction
Keywords
Pacing

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.
Intervention Type
Device
Intervention Name(s)
CRT-D
Intervention Description
Left Ventricular MultiSite Pacing
Primary Outcome Measure Information:
Title
LV MSP Feature Related Complication-Free Rate
Description
Proportion of subjects free from LVMSP feature related complications at 12 months
Time Frame
Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.
Title
Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months
Description
Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months.
Time Frame
12 Month Follow Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects who received de novo implantation of BSC's Resonate family of CRT-D devices with the LV MSP feature4 and BSC's ACUITYTM X4 LV Quadripolar leads. A Resonate family of CRT-D device upgrade from previous single or dual chamber pacemaker or ICD implantation is allowed. Subjects must meet BSC labeled indication for CRT-D implantation. Subjects must have a functional RA lead and RV lead implanted Subjects who are willing and capable of providing informed consent Subjects who are willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol Subjects who are age 18 and above, or of legal age to give informed consent specific to state and national law Exclusion Criteria: Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system implantation. Subjects who received the LV MSP therapy post CRT-D implantation but prior to enrollment Subjects with documented history of permanent AF Subjects with documented permanent complete AV block Subjects who are expected to receive a heart transplant during the 12 months course of the study Subjects with documented life expectancy of less than 12 months Subjects who enrolled in any other concurrent study or registry, with the exception of mandatory national or governmental registry, without prior written approval from BSC
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saba Samir
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Phoenix Cardiovascular Group
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Cardiology Associates of NEA
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Foothill Cardiology Medical Group
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Chula Vista Cardiac Center
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Desert Heart Rhythm Consultants
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Cardiology Associates Medical Group
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Delray Medical Center
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
UF Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Florida Hospital Waterman
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Facility Name
Tallahassee Research Institute
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Alexian Brothers Hospital Network
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Parkview Hospital Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Norton Heart Specialist
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
Advanced Cardiovascular Specialists
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
MedStar Heart and Vascular Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Ascension St. John Hospital & Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
St. Mary's of Michigan Research Institute at Covenant Medical Ceter
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
UMMC- Division of Cardiology
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
St. Lukes Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Methodist Physicians Clinic Heart Consultants
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Deborah Heart and Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Hackensack University Medical Canter
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Durham VA medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
WakeMed
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Trihealth- Good Samaritan & Bethesda North Hospitals
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
St. Elizabeth Youngstown Hospital
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
Salem Health
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Pinnacle Health Cardiovascular Institute
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Berk Cardiologists
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
AnMed Health Clinical Research
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Rapid City Regional Health
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
75501
Country
United States
Facility Name
Stern Cardiovascular Foundation
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Heartplace, PA
City
Bedford
State/Province
Texas
ZIP/Postal Code
76021
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
UT Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Carient Heart and Vascular
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20109
Country
United States
Facility Name
Sentara Norfolk General
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
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

Plan to Share IPD
No

Learn more about this trial

Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)

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