Safety and Performance Study of the INGEVITY Lead



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:8/30/2018
Start Date:October 2012
End Date:January 2019

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INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study

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

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

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
We found this trial at
45
sites
Austin, Texas 78745
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Austin, Texas 78756
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Austin, TX
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Bellingham, Washington 98225
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Bellingham, WA
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Bowling Green, Kentucky 42101
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Bowling Green, KY
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Brisbane, Queensland
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Brisbane,
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506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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Brooklyn, NY
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Canton, Ohio 44710
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Canton, OH
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Charleston, South Carolina
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Charleston, SC
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Cincinnati, OH
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Cincinnati, Ohio 45219
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Columbus, OH
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Dallas, Texas 75231
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Dallas, TX
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Danbury, Connecticut 06810
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Danbury, CT
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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Fort Worth, Texas 76104
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Fort Worth, TX
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Gilbert, Arizona 85297
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Gilbert, AZ
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Glendale, Arizona 85306
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Glendale, AZ
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Glendale, Wisconsin 53212
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Indianapolis, Indiana 46260
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Indianapolis, IN
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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La Mesa, California 91942
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La Mesa, CA
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LaPorte, IN
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Largo, FL
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Madison, Wisconsin 53715
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Marietta, Georgia 30060
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Morgantown, West Virginia 26505
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New Orleans, Louisiana 70121
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Orange, California 92868
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Rancho Mirage, California 92270
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Richmond, Virginia 23230
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Rochester, New York 14621
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Rochester, NY
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Saginaw, Michigan 48601
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Saint Paul, Minnesota 55102
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Salt Lake City, Utah 84132
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7901 Frost Street
San Diego, California 92123
858-939-3400
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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San Diego, CA
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Sewell, NJ
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101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
Spartanburg Regional Medical Center Spartanburg Regional is an integrated healthcare delivery system that provides care...
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475 Seaview Ave
Staten Island, New York 10305
(718) 226-9000
Staten Island University Hospital Staten Island University Hospital is a 714-bed, specialized teaching hospital located...
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Staten Island, NY
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Tampa, Florida 33613
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Tampa, FL
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Toledo, OH
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Trumbull, Connecticut 06611
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Trumbull, CT
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Tucson, Arizona 85712
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Tucson, AZ
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Tyler, TX
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Wheeling, West Virginia 26003
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Wheeling, WV
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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