Safety and Performance Study of the INGEVITY Lead

Boston Scientific

Status

Completed

Conditions

Bradycardia

Sinus Node Dysfunction

Treatments

Device: INGEVITY lead

Study type

Interventional

Funder types

Industry

Identifiers

BSC-CDM00048360

Details and patient eligibility

About

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

Full description

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

Enrollment

1,060 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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