Safety and Performance Study of the INGEVITY Lead
- Conditions
- BradycardiaSinus Node Dysfunction
- Interventions
- Device: INGEVITY lead
- Registration Number
- NCT01688843
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.
- Detailed Description
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1060
- Subject is willing and capable of providing informed consent
- 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
- Subject has or has had any pacing or ICD system implants
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description INGEVITY lead INGEVITY lead INGEVITY lead implant
- Primary Outcome Measures
Name Time Method Effectiveness 1 Lead implant through 3 month follow up The bipolar pacing threshold at 0.5 ms at three months post-implant \< 1.5 V
Effectiveness 2(Right Atrium) Lead implant through 3 month follow up P-wave sensed amplitude at three months post-implant \> 1.5 mV
Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months) Lead implant through 3 month follow up Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 91.4%
Safety 3 - Hazard Rate of Lead-Related Complications Implant through 12 months (including available data beyond 12 months) Hazard rate of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time by evaluating the Weibull shape parameter. A Weibull shape greater than one (\>1), equal to one (=1) and less than one (\<1) indicates accelerating, constant, and decelerating hazard of lead-related complications over time, respectively. This endpoint requires the Weibull shape estimate to be less than 1.
Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months) 3 months through 12 months post implant Lead-related complication-free rate from three months post-implant through twelve months post implant, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 94%.
Effectiveness 2(Right Ventricle) Lead implant through 3 month follow up R-wave sensed amplitude at three months post-implant \> 5 mV
Effectiveness 3 Lead implant through 3 month follow up Clinically acceptable pacing impedance between 300 Ω and 1300 Ω
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (78)
Hospital Clinico Y Provincial
🇪🇸Barcelona, Spain
Wellstar Research Institute
🇺🇸Marietta, Georgia, United States
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
Eisenhower Medical Center
🇺🇸Rancho Mirage, California, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
Sharp Grossmont Hospital
🇺🇸La Mesa, California, United States
Orange County Heart Institute
🇺🇸Orange, California, United States
Danbury Hospital
🇺🇸Danbury, Connecticut, United States
West Florida Cardiology Network, LLC
🇺🇸Largo, Florida, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Indiana University Health La Porte Hospital
🇺🇸LaPorte, Indiana, United States
Southern Kentucky Heart Institute
🇺🇸Bowling Green, Kentucky, 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
Northwest Ohio Cardiology Consultants
🇺🇸Toledo, Ohio, 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
PeaceHealth St. Joseph Medical Center
🇺🇸Bellingham, Washington, United States
Wheaton Franciscan Healthcare
🇺🇸Glendale, Wisconsin, United States
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
St. Andrew's War Memorial Hospital
🇦🇺Brisbane, Queensland, Australia
St. Mary's Madison
🇺🇸Madison, Wisconsin, United States
AZ Groeninge Campus
🇧🇪Kortrijk, Belgium
Klinikum Wels-Grieskirchen GmbH
🇦🇹Wels, Austria
Universitair Ziekenhuis Gent
🇧🇪Gent, 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
Roskilde University Hospital
🇩🇰Roskilde, Denmark
CHU La Timone Hospital
🇫🇷Marseille Cedex 05, France
Uniklinik Köln
🇩🇪Cologne, Germany
Kardiologische Gemeinschaftspraxis Kaltofen Schubert Gerner
🇩🇪Chemnitz, Germany
NCN Nouvelles Cliniques Nantaises
🇫🇷Nantes Cedex 2, France
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Otto-von-Guericke-Universitaet Magdeburg
🇩🇪Magdeburg, Germany
Hospital Doctor Peset
🇪🇸Valencia, Spain
Clinico de Valladolid
🇪🇸Valladolid, Spain
Sahlgrenska University Hospital
🇸🇪Göteborg, Sweden
Belfast City Hospital
🇬🇧Belfast, United Kingdom
Pima Heart Physicians, PC
🇺🇸Tucson, Arizona, United States
Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States
Cardiovascular Consultants, LTD
🇺🇸Glendale, Arizona, United States
Cardiology Associates of Fairfield County
🇺🇸Trumbull, Connecticut, United States
Monongalia General Hospital
🇺🇸Morgantown, West Virginia, United States
Medizinische Univ.-Kliniken Graz
🇦🇹Graz, Austria
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Institut Jantung Negara
🇲🇾Kuala Lumpur, Malaysia
University of Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Chiang Mai Heart Center Medical School Hospital
🇹ðŸ‡Chiang Mai, Thailand
Centro Hospitalar do Porto - Hospital de Santo Antonio
🇵🇹Porto, Portugal
Hospital de Santarem
🇵🇹Santarem, Portugal
St. Vincent's Hospital
🇺🇸Indianapolis, Indiana, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
AKH Linz
🇦🇹Linz, Austria
Basildon and Thurrock University Hospitals NHS
🇬🇧Basildon, Essex, United Kingdom
Lindner Center for Research and Education at Christ Hosp
🇺🇸Cincinnati, Ohio, United States
University Hospital, Inc.
🇺🇸Cincinnati, Ohio, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
University of Utah Hospital and Clinics
🇺🇸Salt Lake City, Utah, United States
Skejby Sygehus
🇩🇰Aarhus, Denmark
Azienda Ospedaliera Universitaria Integrata di Verona
🇮🇹Verona, Italy
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Wrexham Maelor Hospital
🇬🇧Wrexham, United Kingdom
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Hospital Universitario Nuestra Senora de Candelaria
🇪🇸Santa Cruz de Tenerife, Spain
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Coastal Cardiology
🇺🇸Charleston, South Carolina, United States
Bon Secours Heart & Vascular Institute
🇺🇸Richmond, Virginia, United States
University Community Hospital
🇺🇸Tampa, Florida, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
South Austin Hospital
🇺🇸Austin, Texas, United States
Heart Hospital of Austin
🇺🇸Austin, Texas, United States
Wheeling Hospital Inc.
🇺🇸Wheeling, West Virginia, United States
Prince of Wales Hospital
ðŸ‡ðŸ‡°Shatin, Hong Kong