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

Brief Title

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

Official Title

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

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.

Study Type

Observational [Patient Registry]

Primary Outcome

Mortality

Secondary Outcome

 Stroke

Condition

Aortic Stenosis Symptomatic

Intervention

Transcatheter Aortic Valve Implantation

Study Arms / Comparison Groups

 Symptomatic Severe Aortic Valve Stenosis

Description:  Patients >18 years old with symptomatic severe aortic valve stenosis.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

Start Date

January 5, 2021

Completion Date

July 30, 2023

Primary Completion Date

December 30, 2022

Eligibility Criteria

        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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Vlad A Iliescu, MD PhD, +40773842692, [email protected]

Location Countries

Romania

Location Countries

Romania

Administrative Informations

NCT ID

NCT04694859

Organization ID

RO-TAVI

Responsible Party

Sponsor

Study Sponsor

Romanian Society of Cardiology

Study Sponsor

Vlad A Iliescu, MD PhD, Principal Investigator, University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania

Verification Date

December 2020