Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
2169 participants
OBSERVATIONAL
2016-07-31
2019-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MPP Programming
This post-market study was designed to characterize the real-world use of MPP technology in patients indicated for CRT device implant. Therefore in order to adequately characterize MPP, data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group.
MPP
MPP ON within 1 month post implant and then continuously programmed ON until 12 months (i.e., MPP ON for months 1-12 continuously)
BiV/MPP
MPP ON at the 12-month study visit and for at least 3 continuous months prior to 12-month assessment (i.e., BiV pacing ON at some point in months 1-9 and MPP ON for months 10-12)
Interventions
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MPP
MPP ON within 1 month post implant and then continuously programmed ON until 12 months (i.e., MPP ON for months 1-12 continuously)
BiV/MPP
MPP ON at the 12-month study visit and for at least 3 continuous months prior to 12-month assessment (i.e., BiV pacing ON at some point in months 1-9 and MPP ON for months 10-12)
Eligibility Criteria
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Inclusion Criteria
* Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria
* Have an epicardial ventricular lead system (Active or Inactive)
* Are less than 18 years of age
* Are currently participating in a clinical investigation including an active treatment arm and belong to the active arm
* Are not expected to complete the study follow-up schedule or duration due to any health condition other than heart failure, such as malignancy, indication for heart transplant or hospice care
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Clay Cohorn
Role: STUDY_DIRECTOR
Abbott Medical Devices
Locations
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University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Heart Center Research, LLC.
Huntsville, Alabama, United States
Integrated Medical Services
Avondale, Arizona, United States
Cardiovascular Consultants Ltd
Glendale, Arizona, United States
Arizona Arrhythmia Research Center
Phoenix, Arizona, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
John C. Lincoln North Mountain Hospital
Phoenix, Arizona, United States
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States
Comprehensive Cardiovascular Specialists
Alhambra, California, United States
USC University Hospital
Los Angeles, California, United States
Jeffrey Goodman
Los Angeles, California, United States
Premier Cardiology, Inc
Newport Beach, California, United States
Desert Heart Rhythm Consultants
Palm Springs, California, United States
Chaparral Medical Group
Pomona, California, United States
Cardiac Rhythm Specialists, Inc.
Reseda, California, United States
San Diego Cardiac Center
San Diego, California, United States
COR Healthcare Medical Associates
Torrance, California, United States
Aurora Denver Cardiology Associates, P.C.
Aurora, Colorado, United States
Cardiology Associates of Fairfield County, PC
Norwalk, Connecticut, United States
Cardiac Arrhythmia Services
Boca Raton, Florida, United States
Yoel R. Vivas, MD
Delray Beach, Florida, United States
Heart Rhythm Solutions
Hollywood, Florida, United States
Citrus Cardiology Consultants, PA
Inverness, Florida, United States
St. Vincent's Medical Center
Jacksonville, Florida, United States
Naushad Shaik, MD
Kissimmee, Florida, United States
Jorge Diaz, M.D., P.A.
Lake Mary, Florida, United States
Central Florida Medical Research
New Smyrna Beach, Florida, United States
Usman R. Siddiqui, MD
Orlando, Florida, United States
Sacred Heart Hospital
Pensacola, Florida, United States
Brevard Cardiovascular Research Associates, Inc.
Rockledge, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
VA Medical Center - Tampa
Tampa, Florida, United States
Piedmont Athens Regional Medical Center
Athens, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Coliseum Medical Centers
Macon, Georgia, United States
Redmond Regional Medical Center
Rome, Georgia, United States
Illinois Heart and Vascular - Hinsdale
Hinsdale, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Reid Health
Richmond, Indiana, United States
Healient Physician Group
Leawood, Kansas, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Jewish Hospital
Louisville, Kentucky, United States
One Health Cardiology
Owensboro, Kentucky, United States
Gregory C. Sampognaro Interventional Cardiology
Monroe, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Advanced Cardiovascular Specialists
Shreveport, Louisiana, United States
LSU Health Sciences Center
Shreveport, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
MedStar Health Research Institute
Hyattsville, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Charlton Memorial Hospital
Fall River, Massachusetts, United States
Trinity Health-Michigan d/b/a Michigan Heart
Ann Arbor, Michigan, United States
Michigan Electrophysiology Specialists
Flushing, Michigan, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
MidMichigan Medical Center-Midland
Midland, Michigan, United States
Michigan Cardiovascular Institute
Saginaw, Michigan, United States
Providence Hospital
Southfield, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
St. Louis Heart and Vascular PC
St Louis, Missouri, United States
Kearney Regional Medical Center
Kearney, Nebraska, United States
BryanLGH Medical Center East
Lincoln, Nebraska, United States
HealthCare Partners Cardiology
Las Vegas, Nevada, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Atlantic Health System - Morristown Memorial Hospital
Morristown, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Presbyterian Heart Group
Albuquerque, New Mexico, United States
St. Peter's Health Partners Medical Associates, PC
Albany, New York, United States
Trinity Medical WNY, PC
Buffalo, New York, United States
Novant Health Heart and Vascular Research Institute
Charlotte, North Carolina, United States
VA Medical Center Durham
Durham, North Carolina, United States
Highpoint Regional Hospital
High Point, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
University Hospitals Elyria Medical Center
Elyria, Ohio, United States
Middletown Cardiovascular Associates
Middletown, Ohio, United States
Samaritan Heart & Vascular Institute - Cardiology Dept.
Corvallis, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Presbyterian Medical Center (PA)
Philadelphia, Pennsylvania, United States
Scranton Cardiovascular Physicians
Scranton, Pennsylvania, United States
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, United States
Pee Dee Cardiology Associates, PA
Florence, South Carolina, United States
St. Francis Hospital
Greenville, South Carolina, United States
Lexington Cardiology
Lexington, South Carolina, United States
Mountain States Medical Group Cardiology
Johnson City, Tennessee, United States
Cardiovascular Associates, PC (Wellmont Holston Valley M C)
Kingsport, Tennessee, United States
Methodist University Hospital
Memphis, Tennessee, United States
Austin Heart
Austin, Texas, United States
HeartPlace
Bedford, Texas, United States
Fort Worth Heart
Fort Worth, Texas, United States
Houston Cardiovascular Associates
Houston, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, United States
Cardiology Clinic Of San Antonio Pa
San Antonio, Texas, United States
Wichita Falls Heart Clinic
Wichita Falls, Texas, United States
McKay-Dee Heart Services
Ogden, Utah, United States
University of Utah Hospital
Salt Lake City, Utah, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Virginia Heart - The Cardiovascular Group, P.C.
Falls Church, Virginia, United States
Bayview Physicians Services, PC
Virginia Beach, Virginia, United States
Kootenai Heart Clinics
Spokane, Washington, United States
St. Mary's Hospital
Huntington, West Virginia, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Aspirus Wausau Hospital
Wausau, Wisconsin, United States
Wheaton Franciscan Medical Group - Heart Rhythm Specialists
Wauwatosa, Wisconsin, United States
Instituto Argentino de Diagnostico y Tratamiento
Caba, Buenos Aires, Argentina
Fundacion Favaloro para la Docencia e Inv. med.
Buenos Aires, Rio de La Plata, Argentina
Instituto Cardiovascular Buenos Aires (ICBA)
Buenos Aires, Rio de La Plata, Argentina
Fundacion Clinica Shaio
Bogota, Antioquia, Colombia
APEX Foundation
Medellín, Antioquia, Colombia
Hirosaki University Hospital
Hirosaki, Aomori, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Akashi Medical Center
Hyōgo, Kinki, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Tokyo Women's Medical University
Shinjuku-Ku, Tokyo, Japan
Chiba University
Chiba, , Japan
St. Marianna University School of Medicine Hospital
Kanagawa, , Japan
Shinshu University Hospital
Matsumoto, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Sakurabashi Watanabe Hospital
Osaka, , Japan
National Cerebral and Cardiovascular Center Hospital
Osaka, , Japan
Osaka University Hospital
Osaka, , Japan
University of Tsukuba Hospital
Tsukuba, , Japan
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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SJM-CIP-10149
Identifier Type: -
Identifier Source: org_study_id
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