Clinical trial NCT01688843: Safety and Performance Study of the INGEVITY Lead
Official title: INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Sinus Node Dysfunction
Keywords: bradycardia
sinus node dysfunction
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-09-20
Enrollment: 1060
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)
timeFrame: Lead implant through 3 month follow up
measure: Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)
timeFrame: 3 months through 12 months post implant
measure: Safety 3 - Hazard Rate of Lead-Related Complications
timeFrame: Implant through 12 months (including available data beyond 12 months)
measure: Effectiveness 1
timeFrame: Lead implant through 3 month follow up
measure: Effectiveness 2(Right Atrium)
timeFrame: Lead implant through 3 month follow up
measure: Effectiveness 2(Right Ventricle)
timeFrame: Lead implant through 3 month follow up
measure: Effectiveness 3
timeFrame: Lead implant through 3 month follow up
Secondary outcomes:
Other outcomes:
measure: Ancillary Safety
timeFrame: From 3 to 60 months post-implant
Locations:
city: Gilbert
country: United States
facility: Mercy Gilbert Medical Center
state: Arizona
city: Glendale
country: United States
facility: Cardiovascular Consultants, LTD
state: Arizona
city: Tucson
country: United States
facility: Pima Heart Physicians, PC
state: Arizona
city: La Mesa
country: United States
facility: Sharp Grossmont Hospital
state: California
city: Orange
country: United States
facility: Orange County Heart Institute
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Danbury
country: United States
facility: Danbury Hospital
state: Connecticut
city: Trumbull
country: United States
facility: Cardiology Associates of Fairfield County
state: Connecticut
city: Largo
country: United States
facility: West Florida Cardiology Network, LLC
state: Florida
city: Tampa
country: United States
facility: University Community Hospital
state: Florida
city: Marietta
country: United States
facility: Wellstar Research Institute
state: Georgia
city: Indianapolis
country: United States
facility: St. Vincent's Hospital
state: Indiana
city: LaPorte
country: United States
facility: Indiana University Health La Porte Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Bowling Green
country: United States
facility: Southern Kentucky Heart Institute
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Saginaw
country: United States
facility: Michigan CardioVascular Institute
state: Michigan
city: Saint Paul
country: United States
facility: HealthEast St. Joseph's Hospital
state: Minnesota
city: Sewell
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Lindner Center for Research and Education at Christ Hosp
state: Ohio
city: Cincinnati
country: United States
facility: University Hospital, Inc.
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Toledo
country: United States
facility: Northwest Ohio Cardiology Consultants
state: Ohio
city: Charleston
country: United States
facility: Coastal Cardiology
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Austin
country: United States
facility: South Austin Hospital
state: Texas
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Dallas
country: United States
facility: North Texas Heart Center
state: Texas
city: Fort Worth
country: United States
facility: Plaza Medical Center of Fort Worth
state: Texas
city: Tyler
country: United States
facility: Trinity Mother Frances Health System
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital and Clinics
state: Utah
city: Richmond
country: United States
facility: Bon Secours Heart & Vascular Institute
state: Virginia
city: Bellingham
country: United States
facility: PeaceHealth St. Joseph Medical Center
state: Washington
city: Morgantown
country: United States
facility: Monongalia General Hospital
state: West Virginia
city: Wheeling
country: United States
facility: Wheeling Hospital Inc.
state: West Virginia
city: Glendale
country: United States
facility: Wheaton Franciscan Healthcare
state: Wisconsin
city: Madison
country: United States
facility: St. Mary's Madison
state: Wisconsin
city: Brisbane
country: Australia
facility: St. Andrew's War Memorial Hospital
state: Queensland
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Graz
country: Austria
facility: Medizinische Univ.-Kliniken Graz
city: Linz
country: Austria
facility: AKH Linz
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge Campus
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Hotel Dieu du Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Aarhus
country: Denmark
facility: Skejby Sygehus
city: Roskilde
country: Denmark
facility: Roskilde University Hospital
city: Marseille Cedex 05
country: France
facility: CHU La Timone Hospital
city: Nantes Cedex 2
country: France
facility: NCN Nouvelles Cliniques Nantaises
city: Chemnitz
country: Germany
facility: Kardiologische Gemeinschaftspraxis Kaltofen Schubert Gerner
city: Cologne
country: Germany
facility: Uniklinik Köln
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universitaet Magdeburg
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto - Hospital de Santo Antonio
city: Santarem
country: Portugal
facility: Hospital de Santarem
city: Barcelona
country: Spain
facility: Hospital Clinico Y Provincial
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Senora de Candelaria
city: Valencia
country: Spain
facility: Hospital Doctor Peset
city: Valladolid
country: Spain
facility: Clinico de Valladolid
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Chiang Mai
country: Thailand
facility: Chiang Mai Heart Center Medical School Hospital
city: Basildon
country: United Kingdom
facility: Basildon and Thurrock University Hospitals NHS
state: Essex
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Wrexham
country: United Kingdom
facility: Wrexham Maelor Hospital
Study officials:
affiliation: Johns Hopkins University
name: Charles Love, MD
role: PRINCIPAL_INVESTIGATOR
References: