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
NA
1060 participants
INTERVENTIONAL
2012-10-31
2019-02-28
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
TREATMENT
NONE
Study Groups
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INGEVITY lead
INGEVITY lead implant
INGEVITY lead
Interventions
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INGEVITY lead
Eligibility Criteria
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Inclusion Criteria
* Subject has a Class I or II indication for implantation of a single(VVI (R) only) or dual chamber pacemaker or a CRT-P system according to the ACC/AHA/HRS, or ESC guidelines
* Subject is 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
* Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion Criteria
* Subject has a sensitivity to dexamethasone acetate (DXA)
* Subject has a mechanical tricuspid heart valve
* Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries
* Subjects with documented permanent or persistent AF where the physician intends to implant dual chamber pulse generator (single chamber VVIR pulse generators in these subjects is acceptable)
* Subject is currently on the active heart transplant list
* Subject has documented life expectancy of less than 12 months
* Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY Lead implant
* Subjects currently requiring dialysis
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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Charles Love, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Mercy Gilbert Medical Center
Gilbert, Arizona, United States
Cardiovascular Consultants, LTD
Glendale, Arizona, United States
Pima Heart Physicians, PC
Tucson, Arizona, United States
Sharp Grossmont Hospital
La Mesa, California, United States
Orange County Heart Institute
Orange, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Danbury Hospital
Danbury, Connecticut, United States
Cardiology Associates of Fairfield County
Trumbull, Connecticut, United States
West Florida Cardiology Network, LLC
Largo, Florida, United States
University Community Hospital
Tampa, Florida, United States
Wellstar Research Institute
Marietta, Georgia, United States
St. Vincent's Hospital
Indianapolis, Indiana, United States
Indiana University Health La Porte Hospital
La Porte, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Southern Kentucky Heart Institute
Bowling Green, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
Michigan CardioVascular Institute
Saginaw, Michigan, United States
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, United States
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, United States
New York Methodist Hospital
Brooklyn, New York, United States
Rochester General Hospital
Rochester, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Aultman Hospital
Canton, Ohio, United States
Lindner Center for Research and Education at Christ Hosp
Cincinnati, Ohio, United States
University Hospital, Inc.
Cincinnati, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Northwest Ohio Cardiology Consultants
Toledo, Ohio, United States
Coastal Cardiology
Charleston, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
South Austin Hospital
Austin, Texas, United States
Heart Hospital of Austin
Austin, Texas, United States
North Texas Heart Center
Dallas, Texas, United States
Plaza Medical Center of Fort Worth
Fort Worth, Texas, United States
Trinity Mother Frances Health System
Tyler, Texas, United States
University of Utah Hospital and Clinics
Salt Lake City, Utah, United States
Bon Secours Heart & Vascular Institute
Richmond, Virginia, United States
PeaceHealth St. Joseph Medical Center
Bellingham, Washington, United States
Monongalia General Hospital
Morgantown, West Virginia, United States
Wheeling Hospital Inc.
Wheeling, West Virginia, United States
Wheaton Franciscan Healthcare
Glendale, Wisconsin, United States
St. Mary's Madison
Madison, Wisconsin, United States
St. Andrew's War Memorial Hospital
Brisbane, Queensland, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Medizinische Univ.-Kliniken Graz
Graz, , Austria
AKH Linz
Linz, , Austria
Klinikum Wels-Grieskirchen GmbH
Wels, , Austria
Universitair Ziekenhuis Gent
Ghent, , Belgium
AZ Groeninge Campus
Kortrijk, , Belgium
Royal Columbian Hospital
New Westminster, British Columbia, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Hopital Hotel Dieu du Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Skejby Sygehus
Aarhus, , Denmark
Roskilde University Hospital
Roskilde, , Denmark
CHU La Timone Hospital
Marseille, , France
NCN Nouvelles Cliniques Nantaises
Nantes, , France
Kardiologische Gemeinschaftspraxis Kaltofen Schubert Gerner
Chemnitz, , Germany
Uniklinik Köln
Cologne, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, , Germany
Prince of Wales Hospital
Shatin, , Hong Kong
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, , Italy
Institut Jantung Negara
Kuala Lumpur, , Malaysia
University of Malaya Medical Centre
Kuala Lumpur, , Malaysia
Centro Hospitalar do Porto - Hospital de Santo Antonio
Porto, , Portugal
Hospital de Santarem
Santarém, , Portugal
Hospital Clinico Y Provincial
Barcelona, , Spain
Hospital Universitario Nuestra Senora de Candelaria
Santa Cruz de Tenerife, , Spain
Hospital Doctor Peset
Valencia, , Spain
Clinico de Valladolid
Valladolid, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Chiang Mai Heart Center Medical School Hospital
Chiang Mai, , Thailand
Basildon and Thurrock University Hospitals NHS
Basildon, Essex, United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
Wrexham Maelor Hospital
Wrexham, , United Kingdom
Countries
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Other Identifiers
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BSC-CDM00048360
Identifier Type: -
Identifier Source: org_study_id
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