CTRI/2024/03/064701尚未招募4 期
A prospective, single-arm, multi-centre, real-world evaluation of theMammoth Balloon Dilatation Catheter’s performance in patients with severe native aortic stenosis undergoing balloon aortic valvuloplasty alone or dilatation prior to Transcatheter Aortic Valve Implantation. - Mammoth BDC-1
Meril Life Sciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients who will be treated with Mammoth BDC as per Investigator’s discretion in severe native aortic stenosis for BAV alone or dilatation prior to the implantation of transcatheter aortic valve. 2. Male and female patients of more than 18 year of age. 3. Patient or his or her legally authorized representative (if applicable) agrees to provide written informed consent as approved by respective Ethics Committee and applicable regulatory authorities.
排除标准
- •1.Patients in whom antiplatelet and or anticoagulant therapy are contraindicated. 2. The patient has had previous aortic valve replacement. 3. Pregnant or lactating women. 4. Any illness or condition which, in the Investigators discretion will compromise patient safety, or interfere with the interpretation of the treatment results.
研究者
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