The objective is to assess the effectiveness of the Mammoth Balloon Dilatation Catheter in patients with a significant narrowing of the main heart valve. This will be evaluated in patients undergoing either a balloon dilation to widen the valve or a minimally invasive valve replacement procedure.
- Conditions
- Health Condition 1: I350- Nonrheumatic aortic (valve) stenosis
- Registration Number
- CTRI/2024/03/064701
- Lead Sponsor
- Meril Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Device successTimepoint: Pre-Procedure
- Secondary Outcome Measures
Name Time Method Serious Adverse Event <br/ ><br>Peri-Procedure Hemodynamic Changes <br/ ><br>Post-Procedure Hemodynamic Changes <br/ ><br>Acute balloon performance <br/ ><br>Acute technical success of Python Introducer Sheath <br/ ><br>Feedback Score for Navigator Transcatheter Heart Valve Delivery System <br/ ><br>Device Success of Navigator Transcatheter Heart Valve Delivery SystemTimepoint: Peri-procedure, Discharge, Immediately after procedure, At Index-procedure