INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study
NCT ID: NCT04346537
Last Updated: 2022-07-14
Study Results
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View full resultsBasic Information
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COMPLETED
109 participants
OBSERVATIONAL
2020-08-06
2021-03-01
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
Interventions
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INGEVITY+™ Pace/Sense Lead
The INGEVITY+ lead is indicated for chronic pacing and sensing in the right atrium and/or right ventricle when used with a compatible pulse generator.
Eligibility Criteria
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Inclusion Criteria
2. Subject is intended to undergo initial (de novo) pacing system implant using INGEVITY+ Leads in the Right Atrium (RA) and Right Ventricle (RV) and a Boston Scientific pulse generator
3. Subject meets an indication for a Boston Scientific Pacemaker or CRT-P device per product labeling (Physician's Technical Manual)
4. 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
5. Age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion Criteria
2. Has a mechanical tricuspid heart valve
3. Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY+ Lead implant (method of assessment upon physician's discretion)
4. Currently requiring hemo- or peritoneal dialysis
5. Subject has or has had implanted any pacing or ICD system, including subcutaneous, transvenous or leadless systems
6. Intended to receive a single chamber device
7. Documented history of permanent or persistent AF
8. Currently on an active organ transplant list
9. Documented life expectancy of less than 12 months
10. Enrolled in any other concurrent study unless prior approval is received from the Sponsor
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Devi Nair, MD
Role: PRINCIPAL_INVESTIGATOR
Arrhythmia Research Group
Locations
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Heart Center Research, LLC
Huntsville, Alabama, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Torrance Memorial Medical Center
Torrance, California, United States
Emory University Hospital
Atlanta, Georgia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Cardiovascular Institute of Michigan
Clinton Township, Michigan, United States
Cox Health
Springfield, Missouri, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Deborah Heart and Lung
Browns Mills, New Jersey, United States
Aultman Hospital
Canton, Ohio, United States
Saint Thomas Health
Nashville, Tennessee, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
PeaceHealth Southwest Medical
Bellingham, Washington, 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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92424682
Identifier Type: -
Identifier Source: org_study_id
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