Project My Heart Your Heart: Prospective Evaluation of the Safety and Efficacy of Cardiac Pacemaker Reuse in Low to Middle Income Countries
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 370
- 试验地点
- 10
- 主要终点
- Freedom from Procedure-Related Infection at 12 months
研究概览
简要总结
Lack of access to pacemakers is a major challenge to the provision of cardiovascular health care in Low and Middle Income Countries (LMIC). Post-mortem pacemaker utilization could be safe, efficacious, and ethically responsible means of delivering the needed care. Reconditioned pacemakers can provide therapy for patients with symptomatic bradycardia and no means of receiving a new device. The objective of the clinical trial is to determine if pacemaker reutilization can be shown to be a safe means of delivering pacemakers to patients in LMIC without resources. Consented patients in this multi-center trial will be randomized to undergo implantation of either a reconditioned device or a new device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Freedom from Procedure-Related Infection at 12 months
时间窗: 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
次要结局
- Freedom from Pacemaker Software or Hardware Malfunction at 12 months(12 months post device implantation)
研究者
Thomas Crawford, MD
Associate Professor
University of Michigan