A prospective single arm multicentre study to assess the safety and effectiveness of the heart valve implantation in Indian population - Patient Registry
- Conditions
- Health Condition 1: I999- Unspecified disorder of circulatory system
- Registration Number
- CTRI/2021/10/037266
- Lead Sponsor
- Advanced Cardiovascular Care Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients who are operable and at any risk for surgical valve replacement. (STS and EuroScore all-risk categories are included)
2. Patient with age more than 65 years with severe symptomatic calcific aortic stenosis requiring aortic valve replacement characterized by one or more of the following within 60 days prior to the index procedure: aortic valve area (AVA) < 0.8 cm,indexed AVA <0.5 cm square/m square, mean gradient > 40mmHg, or peak aortic jet velocity > 4.0m/sec.
3. Patients coming under New York Heart Association (NYHA) Functional Class II or greater
4. The patient or the patientââ?¬•s legal representative will be informed of the nature of the study, agrees to its provisions, and will provide written informed consent as approved by the EC of the respective clinical site.
5. The patient agrees to comply with all required post-procedure follow-up visits.
6. Native aortic valve annulus area between 273 mm square - 683 mm square as measured by CT scan.
7. Native aortic annulus diameter between 18.6 mm ââ?¬â?? 29.5 mm as measured by CT scan.
1. Patients with the evidence of an acute myocardial infarction � 1 month (30 days) before the intended treatment [(defined as Q wave MI, or non-Q wave MI with total CK elevation of CK-MB � twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
2. Presence of aortic valve, which is congenital unicuspid or is noncalcified.
3. Presence of anomalous coronary artery that would interfere with proper placement of the valve.
4. Presence of mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
5. Any therapeutic invasive cardiac procedure, resulting in a permanent implant that is performed within 30 days of the index procedure. Implantation with a permanent pacemaker or implantable cardioverter-defibrillator (ICD) is not considered exclusion criteria.
6. Any patient with a balloon valvuloplasty (BAV) within 30 days of the procedure (unless BAV is a bridge to the procedure after a qualifying echocardiogram)
7. Patients who had suffered a stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure.
8. Patient with Leukopenia (WBC < 3000 cell/mL), Acute Anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/mL)
9. Patient with renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening
10. Patients having untreated clinically significant coronary artery
disease requiring revascularization.
11. Patients in need of emergency interventional/surgical procedures within one-month (30 days) prior to the Transcatheter Aortic Valve Implantation (TAVI) procedure.
12. Patients having hypertrophic cardiomyopathy (HCM with myocardium more than 1.5cm without an identifiable cause) with or without obstruction
13. Patients having severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%
14. Patients with echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
15. Patients having active upper GI bleeding within 3 months (90 days) prior to the procedure.
16. Patients with a known contraindication or hypersensitivity to all anticoagulation regimens or inability to be anticoagulated for the study procedure.
17. Patients having estimated life expectancy < 12 months (365 days) due to carcinomas, chronic liver disease, chronic renal disease, or chronic end-stage pulmonary disease
18. Patients with significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick ( > 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe ââ?¬Å?unfoldingââ?¬? and tortuosity of the thoracic aorta.
19 Patients with Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath
20. Patients currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
21. Pat
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method