A prospective, randomized controlled trial to compare the outcomes of same day vs Day 3 discharge following cardiac implantable electronic device implantation.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to assess the Safety,Quality of life and Economic Impact of same-day discharge versus a standard 3-day discharge following cardiac implantable electronic device (CIED) implantation.
研究概览
简要总结
Aims to determine safety,quality of life ,economic impact between day 1 versus day 3 discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients eligible for CIED.
排除标准
- •Critical Complications Post-Procedure: Significant hematoma at the insertion site.
- •Lead dislodgment or repositioning issues.
- •Suspected or confirmed infection.
- •Re-Implantation Cases: Patients undergoing pacemaker replacement or upgrade to CRT/ICD.
- •Pre-Existing Severe Comorbidities: Advanced renal failure requiring dialysis.
- •Active malignancy.
- •Pregnancy: Pregnant or lactating women.
- •Non-Compliance: Patients unlikely to adhere to follow-up protocols.
- •Patients unable to comprehend study requirements or provide consent.
- •Coexistent Cardiac Complications: Severe heart failure (NYHA Class III-IV).
- •Severe valvular heart disease.
- •Participation in Other Trials: Patients enrolled in another clinical trial that could affect outcomes.
结局指标
主要结局
The primary objective of this study is to assess the Safety,Quality of life and Economic Impact of same-day discharge versus a standard 3-day discharge following cardiac implantable electronic device (CIED) implantation.
时间窗: The primary objective of this study is to assess the Safety,Quality of life and Economic Impact of same-day discharge versus a standard 3-day discharge following cardiac implantable electronic device (CIED) implantation. | Quality of life is assessed at the time of discharge.Safety outcomes are assessed at 6 months .Economic impact at the time of discharge.
次要结局
- 1)Minor and Major complications at 1 month post discharge(2)Severity of Tricuspid Regurgitation at 6 months)
研究者
Dr Duggempudi Lakshmi Narayana
Post graduate institute of medical education and research