NCT04694859

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 5, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

December 31, 2020

Last Update Submit

December 31, 2020

Conditions

Aortic Stenosis SymptomaticAortic Valve Stenosis

Keywords

aortic stenosis

Outcome Measures

Primary Outcomes (1)

  • Mortality

    All cause mortality

    1-year

Secondary Outcomes (6)

  • Stroke

    1-year

  • Bleeding

    1-year

  • Myocardial ischemia

    1-year

  • Arrhythmia

    1-year

  • Vascular complications

    1-year

  • +1 more secondary outcomes

Study Arms (1)

Symptomatic Severe Aortic Valve Stenosis

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

Device: Transcatheter Aortic Valve Implantation

Interventions

Transcatheter Aortic Valve ImplantationDEVICE

Transfemoral or transapical Transcatheter Aortic Valve Implantation

Symptomatic Severe Aortic Valve Stenosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 18 years old diagnosed with symptomatic severe aortic valve stenosis undergoing TAVI.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catalina A. Parasca, MD

Bucharest, 030423, Romania

RECRUITING

Related Publications (5)

  • Lindroos M, Kupari M, Heikkila J, Tilvis R. Prevalence of aortic valve abnormalities in the elderly: an echocardiographic study of a random population sample. J Am Coll Cardiol. 1993 Apr;21(5):1220-5. doi: 10.1016/0735-1097(93)90249-z.

    PMID: 8459080BACKGROUND

  • Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers 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. No abstract available.

    PMID: 22922698BACKGROUND

  • Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.

    PMID: 22443479BACKGROUND

  • Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium (VARC)-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60. doi: 10.1093/ejcts/ezs533. Epub 2012 Oct 1.

    PMID: 23026738BACKGROUND

  • Iung B, Delgado V, Rosenhek R, Price S, Prendergast B, Wendler O, De Bonis M, Tribouilloy C, Evangelista A, Bogachev-Prokophiev A, Apor A, Ince H, Laroche C, Popescu BA, Pierard L, Haude M, Hindricks G, Ruschitzka F, Windecker S, Bax JJ, Maggioni A, Vahanian A; EORP VHD II Investigators. Contemporary Presentation and Management of Valvular Heart Disease: The EURObservational Research Programme Valvular Heart Disease II Survey. Circulation. 2019 Oct;140(14):1156-1169. doi: 10.1161/CIRCULATIONAHA.119.041080. Epub 2019 Sep 12.

    PMID: 31510787BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catalina A Parasca, MD

CONTACT

+40773842692catalina.parasca@gmail.com

Bogdan A Popescu, MD PhD

CONTACT

+40722611305bogdan.a.popescu@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2020

First Posted

January 5, 2021

Study Start

January 5, 2021

Primary Completion

December 30, 2022

Study Completion

July 30, 2023

Last Updated

January 5, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)