A prospective, multi-centre, single arm, pivotal clinical study to determine the safety and effectiveness of Crea Aortic Valve for use as a Replacement Aortic Heart Valve
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 10
- Primary Endpoint
- 4. Clinical Efficacy at 3-months
Study Overview
Brief Summary
To evaluate safety and performance outcomes following treatment with the study device in subjects at high surgical risk, as determined by the heart team who require replacement of their native aortic valve due to symptomatic, severe, aortic valve stenosis (AS).High surgical risk is defined as predicted risk of surgical mortality ≥8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator. The total planned study duration is 20 months, which includes an initial recruitment period of 6 months and follow-up period of 12 months and 02-month’s time for post study analysis and site close outs.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male or female at least 18 years of age.
- •Patient provides written informed consent and agrees to all follow-up.
- •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.
- •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
- •Mechanical or biologic prosthesis in the aortic position.
- •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.
- •Known allergy to any device component.
- •Bicuspid aortic valve
- •Ongoing sepsis, including active endocarditis
- •Patient ejection fraction <35%.
- •Patient expected to undergo for coronary intervention within 12 Months.
Outcomes
Primary Outcomes
4. Clinical Efficacy at 3-months
Time Frame: 30 days, 1 month, 3 month , 6 month and 12 months
Device Related:
Time Frame: 30 days, 1 month, 3 month , 6 month and 12 months
1. Technical Success at exit from procedure room.
Time Frame: 30 days, 1 month, 3 month , 6 month and 12 months
2. Device Success at 30 days, or in-hospital if 30-day data are not available.
Time Frame: 30 days, 1 month, 3 month , 6 month and 12 months
3. Early Safety at 30 days.
Time Frame: 30 days, 1 month, 3 month , 6 month and 12 months
5. Clinical Efficacy at 6-months
Time Frame: 30 days, 1 month, 3 month , 6 month and 12 months
6. Clinical Efficacy at 12-months.
Time Frame: 30 days, 1 month, 3 month , 6 month and 12 months
All cause mortality in 30 days.
Time Frame: 30 days, 1 month, 3 month , 6 month and 12 months
Secondary Outcomes
- Patient-Reported Outcomes:(1. NYHA Class (at each follow-up, & change from baseline).)
Investigators
Dr Praveen Chandra
Medanta - The Medicity, Gurgaon