Aortic Stenosis Symptomatic, Aortic Valve Stenosis
Conditions
Keywords
aortic stenosis
Brief summary
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
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.
Interventions
DEVICETranscatheter Aortic Valve Implantation
Transfemoral or transapical Transcatheter Aortic Valve Implantation
Sponsors
Romanian Society of Cardiology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 1-year | All cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding | 1-year | Major bleeding |
| Myocardial ischemia | 1-year | Acute myocardial infarction or recurrent angina |
| Stroke | 1-year | Ischemic or hemorrhagic cerebrovascular accident |
| Vascular complications | 1-year | Procedure related vascular complications |
| Acute kidney injury | 1-year | Procedure related renal dysfunction |
| Arrhythmia | 1-year | Arrhythmias requiring permanent pacemaker implantation |
Countries
Romania
Contacts
Primary ContactCatalina A Parasca, MD
Backup ContactBogdan A Popescu, MD PhD
Outcome results
None listed