Study to evaluate safety and efficacy of TAVI -Transcatheter Aortic Valve (Crea Aortic Valve)

Not Applicable

Conditions: Health Condition 1: I350- Nonrheumatic aortic (valve) stenosis

Registration Number: CTRI/2024/01/061426

Lead Sponsor: Onecrea Medical India

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Male or female at least 18 years of age.

2. Patient provides written informed consent and agrees to all follow-up.

3. Patient life expectancy at least 1 year.

4. Subjects with symptomatic heart disease due to severe native calcific aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy.

5. Patient anatomy is eligible for TAVR treatment with the investigational device per the Indications in the Instructions for Use. The patient’s aortic arch anatomy requirements are as per communication with the Investigator during training. Patient must present the aortic arch of greater than 80 mm diameter or 100 mm shaft should be able to fit in a straight line in the aorta at the arch.

Exclusion Criteria

1. Mechanical or biologic prosthesis in the aortic position.

2. Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated.

3. Known allergy to any device component.

4. Bicuspid aortic valve

5. Ongoing sepsis, including active endocarditis

6. Pregnant (female of childbearing potential only).

7. Patient ejection fraction <35%.

8. Patient expected to undergo for coronary intervention within 12 Months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device Related: <br/ ><br>1. Technical Success at exit from procedure room. <br/ ><br>2. Device Success at 30 days, or in-hospital if 30-day data are not available. <br/ ><br>3. Early Safety at 30 days. <br/ ><br>4. Clinical Efficacy at 3-months <br/ ><br>5. Clinical Efficacy at 6-months <br/ ><br>6. Clinical Efficacy at 12-months. <br/ ><br>All cause mortality in 30 days. <br/ ><br>Timepoint: 30 days, 1 month, 3 month , 6 month and 12 months

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes: <br/ ><br>1. NYHA Class (at each follow-up, & change from baseline). <br/ ><br>2. 6-Minute Walk Test (6MWT [at 6-Mo & 12-Mo, & change from baseline]). <br/ ><br>3. Kansas City Cardiomyopathy Questionnaire (KCCQ [at 12-Mo, with change from baseline]).Timepoint: 30 days, 1 month, 3 month , 6 month & 12 months