Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)
NCT ID: NCT03257436
Last Updated: 2022-01-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
586 participants
INTERVENTIONAL
2018-01-05
2020-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Single Arm
General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.
CRT-D
Left Ventricular MultiSite Pacing
Interventions
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CRT-D
Left Ventricular MultiSite Pacing
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Saba Samir
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center
Locations
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Mobile Infirmary Medical Center
Mobile, Alabama, United States
Phoenix Cardiovascular Group
Phoenix, Arizona, United States
Cardiology Associates of NEA
Jonesboro, Arkansas, United States
Foothill Cardiology Medical Group
Arcadia, California, United States
Chula Vista Cardiac Center
Chula Vista, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Desert Heart Rhythm Consultants
Palm Springs, California, United States
Cardiology Associates Medical Group
Ventura, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Delray Medical Center
Delray Beach, Florida, United States
UF Health Jacksonville
Jacksonville, Florida, United States
Florida Hospital Waterman
Lake Mary, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Augusta University
Augusta, Georgia, United States
Alexian Brothers Hospital Network
Elk Grove Village, Illinois, United States
Carle Foundation Hospital
Urbana, Illinois, United States
Parkview Hospital Inc
Fort Wayne, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Norton Heart Specialist
Louisville, Kentucky, United States
Advanced Cardiovascular Specialists
Shreveport, Louisiana, United States
MedStar Heart and Vascular Institute
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Ascension St. John Hospital & Medical Center
Detroit, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
St. Mary's of Michigan Research Institute at Covenant Medical Ceter
Saginaw, Michigan, United States
UMMC- Division of Cardiology
Jackson, Mississippi, United States
St. Lukes Hospital
Kansas City, Missouri, United States
Billings Clinic
Billings, Montana, United States
Methodist Physicians Clinic Heart Consultants
Omaha, Nebraska, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Hackensack University Medical Canter
Hackensack, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, United States
Durham VA medical Center
Durham, North Carolina, United States
WakeMed
Raleigh, North Carolina, United States
Trihealth- Good Samaritan & Bethesda North Hospitals
Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, United States
Salem Health
Salem, Oregon, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, United States
Berk Cardiologists
Wyomissing, Pennsylvania, United States
AnMed Health Clinical Research
Anderson, South Carolina, United States
Rapid City Regional Health
Rapid City, South Dakota, United States
Stern Cardiovascular Foundation
Germantown, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Heartplace, PA
Bedford, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
UT Health
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Carient Heart and Vascular
Manassas, Virginia, United States
Sentara Norfolk General
Norfolk, Virginia, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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92050975
Identifier Type: -
Identifier Source: org_study_id
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