A prospective, randomized controlled trial to compare the outcomes of same day discharge vs Day - 3 discharge following cardiac implantable electronic device implantation

PGIMER CHANDIGARH1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2021年10月2日最近更新: 2021年3月4日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: PGIMER CHANDIGARH
入组人数: 200
试验地点: 1
主要终点: 1.Pacing lead dislodgement

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomized, single centre, open label trial assessing the feasibility and safety of same day discharge following CIED implantation in comparison to discharge on day 3. Primary end-points of the study includes pacing lead dislodgement and infective complications. Secondary end-points were pocket hematoma and valve damage.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 85.00 Year(s)（—）
性别: All

入选标准

•All adult patients (>18 years old) with indication to CIED implantation according to contemporary guidelines.

排除标准

•1.CIED replacement or upgrading, 2.Cardiac resynchronization therapy (CRT) device implantation, 3.Disabling conditions causing physical and mobility impairment (e.g. severe muscular dystrophies, spinal cord lesions) 4.Autoimmune diseases, 5.Antibiotic use for any reason (including patients who were chronically immunocompromised), 6.Any surgery within the prior 30 days, 7.Previous infection treated in the prior 30 days, 8.Other antibiotic prophylaxis indications (eg, patients with prosthetic heart valves) 9.Hemodynamically unstable, intubated patients 10.Patients with major intra-procedural complications such as pneumothorax, cardiac perforation/pericardial tamponade, haemothorax, myocardial infarction, peripheral embolus, stroke, and deat.

结局指标

主要结局

1.Pacing lead dislodgement

时间窗: 2 years

2.Infective complications

时间窗: 2 years

次要结局

1.Pocket hematoma(2.Valve damage (TR-post procedure vs 6 months))

研究者

发起方

PGIMER CHANDIGARH

申办方类型

Research institution and hospital

研究点 (1)

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