Project My Heart Your Heart: Pacemaker Reuse

• Reconditioned Pacemaker (Device), also known as St. Jude Medical device, Boston Scientific device, Medtronic device: Devices from the three manufacturers below will be used.
• New Pacemaker (Device), also known as St. Jude Medical device, Boston Scientific device, Medtronic device, Biotronik device: Devices from the four manufacturers below will be used.

Primary outcomes

• Freedom from Procedure-Related Infection at 12 months [12 months post device implantation]: Clinical evidence of pacemaker infection includes local signs of inflammation at the generator site such as erythema, warmth, fluctuance, tenderness, purulent drainage, wound dehiscence, or erosion. Device related endocarditis will be reported if the Duke criteria for infective endocarditis are met. Procedure-related infections will be classified as follows: pocket infection, endocarditis, recurrent bacteremia, extrusion of wires or generator

Secondary outcomes

• Freedom from Pacemaker Software or Hardware Malfunction at 12 months [12 months post device implantation]: Pacemaker software or hardware malfunction include unexpected premature battery depletion, device or electrode malfunction, or unexplained patient death.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Life expectancy ≥ 2 years.
* Indications for device implantation must be fulfilled per standard of care. Consistent with 2008 American College of Cardiology / American Heart Association guidelines for device therapy, one of the following class I indications must be met.
* Sinus Node Dysfunction
* Acquired Atrioventricular (AV) Block
* Chronic Bifascicular Block
* Hypersensitive Carotid Syndrome
* Lack of financial ability to pay for a new device must be assessed and documented.
* All other methods of new device acquisition must be exhausted.
* Patient must be agreeable and able to follow-up with the implanting center within 2 weeks for wound check, at 2 months, 6 months, and every 6 months thereafter for routine pacemaker checks.

Exclusion Criteria:

* Severe valvular disease
* Severe pulmonary disease
* End-stage renal disease (creatinine clearance < 30 mL/min) whether or not on dialysis
* Evidence of ongoing systemic infection
* Prior pacemaker or implantable cardioverter-defibrillator implantation
* Significant contraindication to pacemaker implantation per evaluation of the implanting physician (very high risk of complications).
* Presence of any other condition that the local investigator feels would be problematic or would restrict or limit the participation of the patient for the entire study period
* Pregnant women

• Thomas Crawford, MD, Principal investigator, University of Michigan