Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI

Study Overview
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Brief Summary
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RO-TAVI is a national prospective, observational, multi-center registry registry of patients with aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI) to assess patient care and outcomes.

Detailed Description
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Background: Since the establishment of transcatheter aortic valve implantation (TAVI) in Romania in 2015 there has been a growing number of interventions being performed by an increasing number of hospitals throughout the country. In 2018, there were more than 250 implants, which are expected to grow in the following years by about 30% on an annual basis. Objective: This is a national quality assurance initiative to improve patient care and outcomes. It further serves as a database for the assessment of the safety and efficacy of TAVI and its financial implications (e.g. reimbursement). Design: National, prospective, observational, multi-center registry. All centers performing TAVI in Romania; minimum cases per center for inclusion: 20 cases/year-to-date Population: All patients undergoing TAVI in Romania at any of the participating centers with a CE-marked valve of any manufacturer given that they provide written informed consent.

Official Title
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Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI

Conditions
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Aortic Stenosis Symptomatic, Aortic Valve Stenosis

Intervention / Treatment
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* Device: Transcatheter Aortic Valve Implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe symptomatic aortic valve stenosis high risk or patients deemed amenable for TAVI by a multidisciplinary team signed informed consent to participate in the study Exclusion Criteria: inadequate annulus size (<18 mm, >29 mm) left ventricle thrombus active endocarditis high risk of coronary ostium obstruction plaques with mobile thrombi in the ascending aorta, or arch hemodynamic instability estimated life expectancy <1 year comorbidity suggesting lack of improvement of quality of life other situations adjudicated by the local HeartTeam

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic Severe Aortic Valve Stenosis<br>Patients >18 years old with symptomatic severe aortic valve stenosis. | Device: Transcatheter Aortic Valve Implantation<br>* Transfemoral or transapical Transcatheter Aortic Valve Implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | All cause mortality | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke | Ischemic or hemorrhagic cerebrovascular accident | 1-year | 
| Bleeding | Major bleeding | 1-year | 
| Myocardial ischemia | Acute myocardial infarction or recurrent angina | 1-year | 
| Arrhythmia | Arrhythmias requiring permanent pacemaker implantation | 1-year | 
| Vascular complications | Procedure related vascular complications | 1-year | 
| Acute kidney injury | Procedure related renal dysfunction | 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic stenosis