Safety and Performance Study of the INGEVITY Lead

Completed · Not applicable

Conditions studied: Bradycardia, Sinus Node Dysfunction

In brief

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

Key facts

Study ID

NCT01688843

Run by

Boston Scientific Corporation

People needed

1060

Starts

2012-10-01

Expected to finish

2019-02-01

Last updated by the study team

2020-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Mercy Gilbert Medical Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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