Quadripolar Pacing PAS
|Principal Investigator: FrederickHan|
|Keywords: Heart Failure , Cardiac Device||Department: Cardiovascular Medicine|
|IRB Number: 00058471||Co Investigator:|
|Specialty: Cardiology, Cardiology, Cardiology, Cardiology|
|Sub Specialties: Interventional Cardiology, General Cardiology, Heart Failure|
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.
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
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