INGEVITY

Overview

Status: Not yet recruiting
Keywords: Pacemaker
IRB Number: 00061040
Specialty: Cardiology
Sub Specialties: Cardiac Electrophysiology

Brief Summary

The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY Active Fixation and Passive Fixation Pace/ Sense Leads.

 

Background and Introduction information comes from our attached ICF.

All remaining references are included within attached Company Protocol.

P. 14 (study purpose/objectives)

P. 21-26 (visit details)

P. 27-43 (Statistical methods, data analysis)

Principal Investigator: Roger Freedman
Department: Cardiology
Co Investigator:

Contact Information

Name:Jamila Roehrig
Phone: 801-213-2521
Email: jamila.roehrig@hsc.utah.edu

Inclusion Criteria

 

• Willing and capable of providing informed consent
• INGEVITY Lead(s) and a Boston Scientific pulse generator must be the initial (de novo) pacing system implants for the patient
• Has a Class I or II indication for implantation of a single (VVI(R) only) or dual chamber pacemaker or CRT-P system according to the ACC/AHA/HRS4, or ESC guidelines5
• 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

Exclusion Criteria

 

• Has or has had any pacing or ICD system implants
• Intended to receive an AAI(R) pulse generator
• Known or suspected sensitivity to dexamethasone acetate (DXA)
• Has a mechanical tricuspid heart valve
• Enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries* that are not in conflict and do not affect the following:
• Schedule of procedures for the INGEVITY Study (i.e. should not cause additional or missed visits);
• INGEVITY Study outcome (i.e. involve medications that could affect pacing thresholds);
• Conduct of the INGEVITY Study per GCP/ ISO 14155:2011/ 21 CFR 812/ local regulations
• Documented permanent or persistent AF6 where the physician intends to implant a dual chamber pulse generator (single chamber VVIR pulse generators are acceptable)
• Currently on the active heart transplant list
• 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 (method of assessment upon physician‘s discretion)
• Currently requiring dialysis
*Sponsors of such studies/registries should be