Project My Heart Your Heart: Pacemaker Reuse

Launched by UNIVERSITY OF MICHIGAN · Jul 8, 2019

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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