INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

Completed

Conditions studied: Bradycardia

In brief

The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.

Key facts

Study ID

NCT04346537

Run by

Boston Scientific Corporation

People needed

109

Starts

2020-08-06

Expected to finish

2021-03-01

Last updated by the study team

2022-07-14

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 is intended to undergo initial (de novo) pacing system implant using INGEVITY+ Leads in the Right Atrium (RA) and Right Ventricle (RV) and a Boston Scientific pulse generator
• Subject meets an indication for a Boston Scientific Pacemaker or CRT-P device per product labeling (Physician's Technical Manual)
• 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
• Age 18 or above, or of legal age to give informed consent specific to state and national law

You may not qualify if…

• Known or suspected sensitivity to dexamethasone acetate (DXA)
• Has a mechanical tricuspid heart valve
• Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY+ Lead implant (method of assessment upon physician's discretion)
• Currently requiring hemo- or peritoneal dialysis
• Subject has or has had implanted any pacing or ICD system, including subcutaneous, transvenous or leadless systems
• Intended to receive a single chamber device
• Documented history of permanent or persistent AF
• Currently on an active organ transplant list
• Documented life expectancy of less than 12 months
• Enrolled in any other concurrent study unless prior approval is received from the Sponsor

Where it is running

• Heart Center Research, LLC — Huntsville, Alabama, United States
• Arrhythmia Research Group — Jonesboro, Arkansas, United States
• Torrance Memorial Medical Center — Torrance, California, United States
• Emory University Hospital — Atlanta, Georgia, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Cardiovascular Institute of Michigan — Clinton Township, Michigan, United States
• Cox Health — Springfield, Missouri, United States
• Catholic Medical Center — Manchester, New Hampshire, United States
• Deborah Heart and Lung — Browns Mills, New Jersey, United States
• Aultman Hospital — Canton, Ohio, United States
• Saint Thomas Health — Nashville, Tennessee, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States
• PeaceHealth Southwest Medical — Bellingham, Washington, United States

Full record on ClinicalTrials.gov

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