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

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ClinicalTrials.gov Identifier: NCT04694859
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Romanian Society of Cardiology

Study Description
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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.

Condition or disease Intervention/treatment
Aortic Stenosis Symptomatic Aortic Valve Stenosis Device: Transcatheter Aortic Valve Implantation

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI
Estimated Study Start Date : January 5, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Symptomatic Severe Aortic Valve Stenosis
Patients >18 years old with symptomatic severe aortic valve stenosis.
 Device: Transcatheter Aortic Valve Implantation
Transfemoral or transapical Transcatheter Aortic Valve Implantation


Outcome Measures
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Primary Outcome Measures :
  1. Mortality [ Time Frame: 1-year ]
    All cause mortality


Secondary Outcome Measures :
  1. Stroke [ Time Frame: 1-year ]
    Ischemic or hemorrhagic cerebrovascular accident

  2. Bleeding [ Time Frame: 1-year ]
    Major bleeding

  3. Myocardial ischemia [ Time Frame: 1-year ]
    Acute myocardial infarction or recurrent angina

  4. Arrhythmia [ Time Frame: 1-year ]
    Arrhythmias requiring permanent pacemaker implantation

  5. Vascular complications [ Time Frame: 1-year ]
    Procedure related vascular complications

  6. Acute kidney injury [ Time Frame: 1-year ]
    Procedure related renal dysfunction


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over 18 years old diagnosed with symptomatic severe aortic valve stenosis undergoing TAVI.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04694859


Contacts
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Contact: Catalina A Parasca, MD +40773842692 catalina.parasca@gmail.com
Contact: Bogdan A Popescu, MD PhD +40722611305 bogdan.a.popescu@gmail.com

Locations
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Romania
Catalina A. Parasca, MD Recruiting
Bucuresti, Romania, 030423
Contact: Catalina A Parasca, MD    +40773842692    catalina.parasca@gmail.com   
Contact: Vlad A Iliescu, MD PhD    +40722244055    vladanton.iliescu@gmail.com   
Sub-Investigator: Dan Deleanu, MD PhD         
Sub-Investigator: Ovidiu Chioncel, MD PhD         
Sub-Investigator: Stefan Mot, MD PhD         
Sub-Investigator: Cristian Udroiu, MD         
Sub-Investigator: Horatiu Moldovan, MD PhD         
Sub-Investigator: Grigore Tinica, MD PhD         
Sub-Investigator: Horatiu Suciu, MD PhD         
Sponsors and Collaborators
Romanian Society of Cardiology
Investigators
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Principal Investigator: Vlad A Iliescu, MD PhD University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania
Principal Investigator: Bogdan A Popescu, MD PhD University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania
Principal Investigator: Dragos Vinereanu, MD PhD University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania
More Information
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Publications:
Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schäfers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25.

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Responsible Party: Romanian Society of Cardiology
ClinicalTrials.gov Identifier: NCT04694859    
Other Study ID Numbers: RO-TAVI
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Romanian Society of Cardiology:
aortic stenosis
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Aortic Valve Disease
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction