A PMCF study to evaluate the safety and efficacy of the Bovine Pericardial Tissue Patch
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- 1. To assess the patch performance in terms of preoperative imaging, surgical handling, postoperative outcomes and follow-up echocardiography
研究概览
简要总结
The study will be single centric, prospective, interventional clinical study. Patients undergoing cardiac surgery requiring a patch for intracardiac or extracardiac repair; willing to participate and provide informed consent will be recruited for the study after meeting the inclusion criteria.
Intervention planned: Administration of bovine pericardial patch during cardiac surgery for intracardiac or extracardiac repair.
Comparison: Pre and post operative ECHO and clinical assessment of cardiac surgery patients.
Data Collection: Data will be collected through medical records, intraoperative observations, postoperative follow-up visits, and imaging studies. Patient demographics, preoperative conditions, and intraoperative details will be documented. Adverse events and complications will be systematically recorded and graded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Month(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing cardiac surgery requiring a patch for intracardiac or extracardiac repair.
排除标准
- •Patients with known allergies to bovine products or pre-existing conditions contraindicating the use of bovine pericardial patches.
结局指标
主要结局
1. To assess the patch performance in terms of preoperative imaging, surgical handling, postoperative outcomes and follow-up echocardiography
时间窗: Postoperatively: | 1. 1 month | 2. 3rd month | 3. 6th month | 4. Last Follow-up 1 year
2. To study the safety in terms of Patch-related complication and Intra & postoperative complications
时间窗: Postoperatively: | 1. 1 month | 2. 3rd month | 3. 6th month | 4. Last Follow-up 1 year
次要结局
- To study the effectiveness of the Bovine Pericardial Tissue Patch Handling characteristics, Patient outcome: ICU days, Hospital days, follow-up echo for cardiac surgery patients to look for(patch integrity & Mortality & reoperation rates)
研究者
Dr Vishal V Bhende
Bhanubhai and Madhuben Patel Cardiac Centre