Quadripolar Pacing PAS

Overview

Status: Recruiting
Keywords: Heart Failure , Cardiac Device
IRB Number: 00058471
Specialty: Cardiology, Cardiology, Cardiology, Cardiology
Sub Specialties: Interventional Cardiology, General Cardiology, Heart Failure

Brief Summary

The purpose of this PAS is to evaluate the acute and chronic performance of a Quadripolar CRT-D device system in a patient population indicated for cardiac resynchronization therapy.

Principal Investigator: Nazem Akoum
Department: Cardiology
Co Investigator:

Contact Information

Name:Marci Fjelstad
Phone: 8012133775
Email: marci.fjelstad@carma.utah.edu

Inclusion Criteria

Eligible patients will meet all of the following:

1. Approved indication per current ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or life threatening ventricular tachyarrhythmia(s)

2. Participated in the Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study (IDE study), or are receiving a new Quadripolar CRT-D device system implant or are undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement.

3. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria

Patients will be excluded if they meet any of the following:

1. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate

2. Have a life expectancy of less than 5 years due to any condition

3. Be less than 18 years of age