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Aortic Valve StenosisNCT03361046

Polish Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI) Registry

An observational study of Aortic Valve Stenosis and Aortic Valve Insufficiency, run by Medical University of Warsaw at 12 sites in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In the past years a substantial shift away from mechanical heart valves occurred and bioprosthetic heart valves claimed majority of market shares irrespective of patients' age.This indicates that population with failed surgical bioprostheses requiring ViV-TAVI will grow significantly and therefore, meticulous… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)
Type of treatment
Medical device
How many people
150 participants
Where
12 sitesPoland
Study dates
1 Jan 2018to 30 May 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients meeting inclusion criteria will prospectively included in the study. Patients meeting inclusion criteria before the set-up of registry will be included retrospectively.

Who may be able to join

  • Failing surgically implanted aortic bioprosthetic valve (stented/stentless/homograft) demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
  • Qualification for TAVI by decision of the local Heart Team
  • Patient provided written informed consent

Who cannot join

None listed.

Trial locations and contacts

12 sites in 1 country.

Kajetan Grodecki contact

+48660675782

kajetan.grodecki@gmail.com

12 sites in 1 country

Poland12 sites, 12 recruiting

  • Medical University of Bialystok

    Bialystok

    Marek Frank, MD, PhD

    Paweł Kralisz, MD, PhD

    Recruiting

  • Polish-American Heart Clinic

    Bielsko-Biala

    Wojciech Fil, MD, PhD

    Wojciech Domaradzki, MD, PhD

    Recruiting

  • Medical University of Gdansk

    Gdansk

    Dariusz Jagielak, MD, PhD

    Dariusz Ciećwierz, MD, PhD

    Recruiting

  • Medical University of Silesia

    Katowice

    Wojciech Wojakowski, MD, PhD

    Radosław Parma, MD, PhD

    Recruiting

  • Jagiellonian University Medical College

    Krakow

    Dariusz Dudek, MD, PhD

    Recruiting

  • Medical University of Lodz

    Lodz

    Michał Kidawa, MD, PhD

    Recruiting

  • Poznan University of Medical Sciences

    Poznan

    Marek Grygier, MD, PhD

    Maciej Lesiak, MD, PhD

    Recruiting

  • District Hospital 2

    Rzeszów

    Piotr Olszówka, MD, PhD

    Kazimierz Widenka, MD, PhD

    Recruiting

  • Institute of Cardiology

    Warsaw

    Maciej Dąbrowski, MD, PhD

    Adam Witkowski, MD, PhD

    Recruiting

  • Medical University of Warsaw

    Warsaw

    Zenon Huczek, MD, PhD

    Kajetan Grodecki

    Recruiting

  • Wroclaw Medical University

    Wroclaw

    Piotr Kübler, MD, PhD

    Krzysztof Reczuch, MD, PhD

    Recruiting

  • Silesian Center for Heart Diseases

    Zabrze

    Krzysztof Wilczek, MD, PhD

    Marian Zembala, MD, PhD

    Recruiting

Other trials in Poland

About this study

Official title: Evaluation of Clinical Outcomes of Transcatheter Aortic Valve-in-Valve Implantation in Polish Population - Observational Multicenter Registry

In the past years a substantial shift away from mechanical heart valves occurred and bioprosthetic heart valves claimed majority of market shares irrespective of patients' age.This indicates that population with failed surgical bioprostheses requiring ViV-TAVI will grow significantly and therefore, meticulous prospective data collection is necessary for future analyses in order to better understand potential limitations of this procedure.

Read the detailed description

The study is a prospective multicenter evaluation of transcatheter aortic valve-in-valve implantations in Polish health centers.

Duration of this study is expected to be 6 years to ensure that all of the enrolled patients will complete at least 2 years of follow-up.

Being tested
Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)
Keywords
TAVI, valve-in-valve, aortic stenosis
Medical subject headings
Aortic Valve Stenosis, Aortic Valve Insufficiency, Ventricular Outflow Obstruction, Left

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)Device

    Also called Transcatheter Aortic Valve-in-Valve Replacement (ViV-TAVR)

    Patients with failed aortic valve bioprostheses qualified for TAVI due to coexisting illnesses

Study groups in NCT03361046
Study groupRoleWhat they receive
Transcatheter Aortic Valve-in-Valve Implantation CohortNot described
Receives: Device: Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint

    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure
    • NYHA (New York Heart Association) class III or IV functional classification of heart failure
    • Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, Effective Orifice Area (EOA) ≤0.9-1.1 cm2(c) and/or Doppler Velocity Integral (DVI) <0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation

    Measured: From 30 days post procedure to completion of at least 2 years of follow up

Secondary outcomes (3)

  1. VARC defined 'Device success' composite endpoint

    • Absence of procedural mortality AND
    • Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
    • Intended performance of the prosthetic heart valve (no prosthesis - patient mismatch and mean aortic valve gradient ,20 mmHg or peak velocity ,3 m/s, AND no moderate or severe prosthetic valve regurgitation)

    Measured: 30 days

  2. VARC defined "Early Safety" composite endpoint

    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Life-threatening bleeding
    • Acute kidney injury-Stage 2 or 3 (including renal replacement therapy)
    • Coronary artery obstruction requiring intervention
    • Major vascular complication
    • Valve-related dysfunction requiring repeat procedure (Balloon Aortic Valvuloplasty (BAV), Trans Catheter Aortic Valve Implant (TAVI), or Surgical Aortic Valve Replacement (SAVR))

    Measured: 30 days

  3. VARC defined "Time-related valve safety" composite endpoint

    • Structural valve deterioration
    • Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm2cand/or DVI <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
    • Requiring repeat procedure (TAVI or SAVR)
    • Prosthetic valve endocarditis
    • Prosthetic valve thrombosis
    • Thrombo-embolic events (e.g. stroke)
    • VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)

    Measured: From device implant to completion of at least 2 years of follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2017
  2. Study start1 Jan 2018
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion30 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03361046
Sponsor's protocol ID
WUM-VIV
Status last verified
Oct 2020
First submitted
28 Nov 2017
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 23026738

  • McElhinney DB, Cabalka AK, Aboulhosn JA, Eicken A, Boudjemline Y, Schubert S, Himbert D, Asnes JD, Salizzoni S, Bocks ML, Cheatham JP, Momenah TS, Kim DW, Schranz D, Meadows J, Thomson JD, Goldstein BH, Crittendon I 3rd, Fagan TE, Webb JG, Horlick E, Delaney JW, Jones TK, Shahanavaz S, Moretti C, Hainstock MR, Kenny DP, Berger F, Rihal CS, Dvir D; Valve-in-Valve International Database (VIVID) Registry. Transcatheter Tricuspid Valve-in-Valve Implantation for the Treatment of Dysfunctional Surgical Bioprosthetic Valves: An International, Multicenter Registry Study. Circulation. 2016 Apr 19;133(16):1582-93. doi: 10.1161/CIRCULATIONAHA.115.019353. Epub 2016 Mar 18.

    PubMed 26994123

  • Huczek Z, Grodecki K, Scislo P, Wilczek K, Jagielak D, Fil W, Kubler P, Olszowka P, Dabrowski M, Frank M, Grygier M, Kidawa M, Wilimski R, Zelazowska K, Witkowski A, Kochman J, Zembala M, Opolski G, Dvir D, Wojakowski W. Transcatheter aortic valve-in-valve implantation in failed stentless bioprostheses. J Interv Cardiol. 2018 Dec;31(6):861-869. doi: 10.1111/joic.12540. Epub 2018 Jul 15.

    PubMed 30009390

  • Scislo P, Grodecki K, Binczak D, Kochman J, Wilimski R, Huczek Z. Valve-in-valve treatment of dysfunctional aortic bioprostheses - single-centre experience. Postepy Kardiol Interwencyjnej. 2018;14(4):425-428. doi: 10.5114/aic.2018.79872. Epub 2018 Dec 11. No abstract available.

    PubMed 30603033

  • Jonik S, Mazurek M, Rymuza B, Jankowski J, Dabrowski M, Wolny R, Chodor P, Wilczek K, Fil W, Milewski K, Protasiewicz M, Sciborski K, Kaplon-Cieslicka A, Skrobucha A, Hawranek M, Scislo P, Wilimski R, Kochman J, Grabowski M, Grygier M, Witkowski A, Huczek Z. Redo-Transcatheter Aortic Valve Implantation (Redo-TAVI)-Pilot Study from Multicentre Nationwide Registry. J Clin Med. 2025 Nov 14;14(22):8078. doi: 10.3390/jcm14228078.

    PubMed 41303113

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Stenosis and Aortic Valve Insufficiency, run by Medical University of Warsaw at 12 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kajetan Grodecki (+48660675782, kajetan.grodecki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint (time frame: From 30 days post procedure to completion of at least 2 years of follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03361046, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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