Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Acute complication rate
研究概览
简要总结
The purpose of this study is to use real-world evidence to validate that conduction system pacing (CSP), delivered via a Medtronic 3830 catheter-delivered lead and a Medtronic dual-chamber transvenous pacemaker, is a safe and effective alternative to biventricular pacing (BVP) in patients indicated for cardiac resynchronization therapy (CRT) to deliver cardiac physiologic pacing (CPP), as documented in the clinical literature.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dual-chamber CSP cohort:
- •Medicare beneficiaries implanted with a Medtronic dual-chamber transvenous pacemaker on or after the study start date.
- •Lead type and placement data indicating CSP.
- •An indication for CRT.
- •BVP comparator cohort:
- •Medicare beneficiaries implanted with a Medtronic biventricular pacemaker (CRT-P) on or after the study start date.
排除标准
- •Dual-chamber CSP cohort:
- •Evidence of a prior CIED device.
- •Less than 12 months continuous enrollment in Medicare Part A and Part B prior to implant date.
- •Non-Medtronic pacemaker (unable to link to Medtronic device registration data).
- •Missing lead type or placement data.
- •Lead type and placement data indicating non-CSP placement.
- •BVP comparator cohort:
- •Evidence of a prior CIED device.
- •Less than 12 months continuous enrollment in Medicare Part A and Part B prior to implant date.
- •Non-Medtronic pacemaker (unable to link to Medtronic device registration data).
- •Missing lead type or placement data.
结局指标
主要结局
Acute complication rate
时间窗: 30 days
Demonstrate that dual-chamber CSP is non-inferior to BVP on implant safety in patients indicated for CRT. Endpoint: Compare the acute (≤ 30 days) overall complication rate associated with dual chamber CSP vs. BVP. The acute overall complication rate is a composite measure of separate elements of complications (embolism and thrombosis, events at puncture site, cardiac effusion and perforation, device-related complications, and other procedural complications) and reinterventions (lead-related reinterventions, device revisions, replacements, removals, and upgrades to CRT).
Heart Failure Hospitalization Rate
时间窗: 12 months
Demonstrate that dual-chamber CSP is non-inferior to BVP in patients indicated for CRT. Endpoint: Compare the heart failure hospitalization rate associated with CSP vs. BVP in the CRT-indicated population.
次要结局
- Device-Related Reintervention Rate(12 months)
- Heart Failure-All-Cause Mortality Composite(12 months)
- All-Cause Mortality Rate(12 months)