Safety and Performance Study of the INGEVITY Lead

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01688843
First received: September 17, 2012
Last updated: December 9, 2013
Last verified: October 2013
  Purpose

The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.


Condition Intervention
Bradycardia
Sinus Node Dysfunction
Device: INGEVITY lead

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Safety 1 [ Time Frame: Lead implant through 3 month follow up ] [ Designated as safety issue: Yes ]
    Safety of the INGEVITY Leads will be evaluated by the lead-related complication-free rate (CFR) from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead

  • Safety 2 [ Time Frame: 3 months through 12 months post implant ] [ Designated as safety issue: Yes ]
    To satisfy the safety assessment requirements of FDA, safety of the INGEVITY Leads will also be evaluated by the lead-related complication-free rate (CFR) from three months post-implant through twelve months post implant based on complications that are related to the INGEVITY Lead during that period.

  • Effectiveness 1 [ Time Frame: Lead implant through 3 month follow up ] [ Designated as safety issue: No ]
    The first aspect of effectiveness of the INGEVITY Leads will be established by demonstrating that the leads provide clinically acceptable bipolar pacing thresholds at a 0.5 ms pulse width at three months post implant.

  • Effectiveness 2 [ Time Frame: Lead implant through 3 month follow up ] [ Designated as safety issue: No ]
    The second aspect of effectiveness of the INGEVITY Leads will be established by demonstrating that the leads provide clinically acceptable sensing amplitudes at three months post implant.

  • Effectiveness 3 [ Time Frame: Lead implant through 3 month follow up ] [ Designated as safety issue: No ]
    The third aspect of effectiveness of the INGEVITY Leads will be established by demonstrating that the leads provide clinically acceptable pacing impedance at three months post implant.


Secondary Outcome Measures:
  • Safety 3 [ Time Frame: Implant through 12 months (including available data beyond 12 months) ] [ Designated as safety issue: No ]
    Safety Endpoint 3 will characterize the hazard of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time.


Estimated Enrollment: 1030
Study Start Date: October 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INGEVITY lead
INGEVITY lead implant
Device: INGEVITY lead

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688843

  Hide Study Locations
Locations
United States, Arizona
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
Cardiovascular Consultants, LTD
Glendale, Arizona, United States, 85306
Tucson Medical Center Healthcare
Tucson, Arizona, United States, 85712
United States, California
Grossmont Hospital
El Cajon, California, United States, 92021
Marin General Hospital
Greenbrae, California, United States, 94904
St. Joseph Hospital
Orange, California, United States, 92868
Eisenhower Medical Center
Rancho-Mirage, California, United States, 92270-3221
Sharp Memorial Hospital
San Diego, California, United States, 92123
United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06810
Cardiology Associates of Fairfield County
Trumbull, Connecticut, United States, 06611
United States, Florida
Heart and Vascular Institute of Florida
Clearwater, Florida, United States, 33756
University Community Hospital
Tampa, Florida, United States, 33613
United States, Georgia
Wellstar Research Institute
Marietta, Georgia, United States, 30060
St. Joseph's Hospital
Savannah, Georgia, United States, 31419
United States, Indiana
Krannert Institute of Cardiology
Indianapolis, Indiana, United States, 46202
St. Vincent's Hospital
Indianapolis, Indiana, United States, 46260
Indiana University Health La Porte Hospital
LaPorte, Indiana, United States, 46350
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Western Kentucky Heart & Lung
Bowling Green, Kentucky, United States, 42101
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Michigan CardioVascular Institute
Saginaw, Michigan, United States, 48601
United States, Minnesota
HealthEast St. Joseph's Hospital
St. Paul, Minnesota, United States, 55102
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, United States, 08080
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Rochester General Hospital
Rochester, New York, United States, 14621
Staten Island University Hospital
Staten Island, New York, United States, 10309
United States, North Carolina
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Aultman Hospital
Canton, Ohio, United States, 44710
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Lindner Center for Research and Education at Christ Hosp
Cincinnati, Ohio, United States, 45219
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Northwest Ohio Cardiology Consultants
Toledo, Ohio, United States, 43615
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
United States, South Carolina
Coastal Cardiology
Charleston, South Carolina, United States, 29407
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Texas
Seton Medical Center
Austin, Texas, United States, 78705
Heart Hospital of Austin
Austin, Texas, United States, 78756
South Austin Hospital
Austin, Texas, United States, 78745
North Texas Heart Center
Dallas, Texas, United States, 75231
Plaza Medical Center of Fort Worth
Ft. Worth, Texas, United States, 76104
Trinity Mother Frances Health System
Tyler, Texas, United States, 75701
United States, Utah
University of Utah Hospital and Clinics
Salt Lake City, Utah, United States, 84132
United States, Virginia
Bon Secours Heart & Vascular Institute
Richmond, Virginia, United States, 23230
United States, Washington
St. Joseph Hospital
Bellingham, Washington, United States, 98225
United States, West Virginia
Monongalia General Hospital
Morgantown, West Virginia, United States, 26505
Wheeling Hospital Inc.
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Wheaton Franciscan Healthcare
Glendale, Wisconsin, United States, 53212
St. Mary's Madison
Madison, Wisconsin, United States, 53715
Australia, Queensland
St. Andrew's War Memorial Hospital
Brisbane, Queensland, Australia, 4001
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Austria
AKH Linz
Linz, Austria, 4021
Klinikum Wels-Grieskirchen GmbH
Wels, Austria, 4600
Belgium
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
AZ Groeninge Campus
Kortrijk, Belgium, 8500
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Canada, Quebec
Hopital Hotel Dieu du Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2W IT7
Denmark
Aarhus University Hospital- Skejby Sygehus
Aarhus, Denmark, 8200
Roskilde University Hospital
Roskilde, Denmark, 4000
France
CHU La Timone Hospital
Marseille Cedex 05, France, 13005
NCN Nouvelles Cliniques Nantaises
Nantes Cedex 2, France, 44277
Germany
Kardiologische Gemeinschaftspraxis Kaltofen Schubert Gerner Jurowsky
Chemnitz, Germany, 09116
Uniklinik Köln
Cologne, Germany, 50931
Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, Germany, 39120
Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong, 999077
Italy
Ospedale dei Pellegrini
Napoli, Italy, 80141
Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Malaysia, 50603
Institut Jantung Negara
Kuala Lumpur, Malaysia, 50400
Portugal
Centro Hospitalar de Coimbra
Coimbra, Portugal, P-3001
Centro Hospitalar do Porto - Hospital de Santo Antonio
Porto, Portugal, 4099 - 001
Hospital de Santarem
Santarem, Portugal, 2005-177
Spain
Hospital Clinico Y Provincial
Barcelona, Spain, 08036
Hospital Universitario Nuestra Senora de Candelaria
Santa Cruz de Tenerife, Spain, 38010
Hospital Doctor Peset
Valencia, Spain, 46017
Clinico de Valladolid
Valladolid, Spain, 47012
Sweden
Sahlgrenska University Hospital
Göteborg, Sweden, 41345
Karolinska University Hospital
Stockholm, Sweden
Thailand
Chiang Mai Heart Center Medical School Hospital
Chiang Mai, Thailand, 50200
United Kingdom
Belfast City Hospital
Belfast, United Kingdom, BT9 7
Basildon and Thurrock University Hospitals NHS
Essex, United Kingdom, SS16 5NL
Wrexham Maelor Hospital
Wrexham, United Kingdom, LL13 7TD
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Charles Love, MD The Ohio State University Wexner Medical Center, Ohio, USA
Principal Investigator: Jens Cosedis-Nielsen, Prof. M.D. Aarhus University Hospital, Aarhus, Denmark
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01688843     History of Changes
Other Study ID Numbers: BSC-CDM00048360
Study First Received: September 17, 2012
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
bradycardia
sinus node dysfunction

Additional relevant MeSH terms:
Sick Sinus Syndrome
Bradycardia
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014