Study Results
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View full resultsBasic Information
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TERMINATED
901 participants
OBSERVATIONAL
2017-05-18
2019-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Able to understand the nature of the registry and provide informed consent
* Available for follow-up visits on a regular basis at the study site for the expected 5 years of follow-up
* Accepts BIOTRONIK Home Monitoring® concept
* Age greater than or equal to 18 years
Exclusion Criteria
* Enrolled in BIOTRONIK's QP ExCELs lead study
* Planned cardiac surgical procedures or interventional measures within the next 6 months
* Expected to receive heart transplantation or ventricular assist device within 1 year
* Life expectancy of less than 1 year
* Patients reporting pregnancy at the time of enrollment
18 Years
ALL
No
Sponsors
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Biotronik, Inc.
INDUSTRY
Responsible Party
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Locations
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Thomas Hospital Research Office
Fairhope, Alabama, United States
Jeffrey S Goodman MD
Los Angeles, California, United States
Eisenhower Desert Cardiology
Rancho Mirage, California, United States
Florida Hospital
Orlando, Florida, United States
Advent Health Tampa
Tampa, Florida, United States
St. Louis Cardiology Consultants
Alton, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Heartland Cardiology
Wichita, Kansas, United States
Research Integrity LLC
Owensboro, Kentucky, United States
Northern Light Cardiology
Bangor, Maine, United States
University of Michigan
Ann Arbor, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
Mercy Clinic Cardiology
Springfield, Missouri, United States
St. Louis Heart and Vascular
St Louis, Missouri, United States
Gateway Cardiovascular Research Center
St Louis, Missouri, United States
Mercy Clinic Heart and Vascular
St Louis, Missouri, United States
Glacier View Research Institute Cardiology
Kalispell, Montana, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Novant Health
Winston-Salem, North Carolina, United States
Sanford Medical Center
Fargo, North Dakota, United States
The Ohio State Wexner Medical Center
Columbus, Ohio, United States
Toledo Cardiology
Toledo, Ohio, United States
The Arrhythmia Institute
Newtown, Pennsylvania, United States
Upstate Cardiology
Greenville, South Carolina, United States
Carolina Heart Specialists
Lancaster, South Carolina, United States
Carolina Cardiology Associates
Rock Hill, South Carolina, United States
Cardiovascular Associates Ltd
Virginia Beach, 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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Plexa Registry
Identifier Type: -
Identifier Source: org_study_id
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