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

NCT03361046 | Unknown DMC FDA Device

• 1 other identifier: WUM-VIV
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 12

Brief 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 prospective data collection is necessary for future analyses in order to better understand potential limitations of this procedure.

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency; Ventricular Outflow Obstruction, Left

Keywords

TAVI; valve-in-valve; aortic stenosis

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (3)

• VARC defined 'Device success' composite endpoint

  30 days

• VARC defined "Early Safety" composite endpoint

  30 days

• VARC defined "Time-related valve safety" composite endpoint

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

Study Arms (1)

Transcatheter Aortic Valve-in-Valve Implantation Cohort

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

Interventions

Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI) DEVICE

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

Also known as: Transcatheter Aortic Valve-in-Valve Replacement (ViV-TAVR)

Transcatheter Aortic Valve-in-Valve Implantation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (12)

Medical University of Bialystok

Bialystok, Poland

RECRUITING

Polish-American Heart Clinic

Bielsko-Biala, Poland

RECRUITING

Medical University of Gdansk

Gdansk, Poland

RECRUITING

Medical University of Silesia

Katowice, Poland

RECRUITING

Jagiellonian University Medical College

Krakow, Poland

RECRUITING

Medical University of Lodz

Lodz, Poland

RECRUITING

Poznan University of Medical Sciences

Poznan, Poland

RECRUITING

District Hospital 2

Rzeszów, Poland

RECRUITING

Institute of Cardiology

Warsaw, Poland

RECRUITING

Medical University of Warsaw

Warsaw, Poland

RECRUITING

Wroclaw Medical University

Wroclaw, Poland

RECRUITING

Silesian Center for Heart Diseases

Zabrze, Poland

RECRUITING

Related Publications (5)

• 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: 23026738 BACKGROUND

• 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.

  PMID: 26994123 BACKGROUND

• 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.

  PMID: 30009390 RESULT

• 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.

  PMID: 30603033 RESULT

• 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.

  PMID: 41303113 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency; Ventricular Outflow Obstruction, Left

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Zenon Huczek, MD, PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

• Wojciech Wojakowski, MD, PhD

  Medical University of Silesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kajetan Grodecki

CONTACT

+48660675782; kajetan.grodecki@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: May 30, 2024
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (12)