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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency; Ventricular Outflow Obstruction, Left
• Intervention / Treatment: Device: Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Poland
  • Białystok, Poland
    • Recruiting
    • Medical University of Bialystok
    • Contact: Marek Frank, MD, PhD
    • Contact: Paweł Kralisz, MD, PhD
  • Bielsko-Biala, Poland
    • Recruiting
    • Polish-American Heart Clinic
    • Contact: Wojciech Fil, MD, PhD
    • Contact: Wojciech Domaradzki, MD, PhD
  • Gdańsk, Poland
    • Recruiting
    • Medical University of Gdańsk
    • Contact: Dariusz Ciećwierz, MD, PhD
  • Katowice, Poland
    • Recruiting
    • Medical University of Silesia
    • Contact: Radosław Parma, MD, PhD
  • Kraków, Poland
    • Recruiting
    • Jagiellonian University Medical College
    • Contact: Dariusz Dudek, MD, PhD
  • Poznań, Poland
    • Recruiting
    • Poznan University of Medical Sciences
    • Contact: Maciej Lesiak, MD, PhD
  • Rzeszów, Poland
    • Recruiting
    • District Hospital 2
    • Contact: Piotr Olszówka, MD, PhD
    • Contact: Kazimierz Widenka, MD, PhD
  • Warsaw, Poland
    • Recruiting
    • Medical University of Warsaw
  • Warsaw, Poland
    • Recruiting
    • Institute of Cardiology
    • Contact: Maciej Dąbrowski, MD, PhD
    • Contact: Adam Witkowski, MD, PhD
  • Wrocław, Poland
    • Recruiting
    • Wroclaw Medical University
    • Contact: Piotr Kübler, MD, PhD
    • Contact: Krzysztof Reczuch, MD, PhD
  • Zabrze, Poland
    • Recruiting
    • Silesian Center for Heart Diseases
    • Contact: Krzysztof Wilczek, MD, PhD
    • Contact: Marian Zembala, MD, PhD
  • Łódź, Poland
    • Recruiting
    • Medical University of Lodz
    • Contact: Michał Kidawa, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transcatheter Aortic Valve-in-Valve Implantation Cohort	Device: Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI); Patients with failed aortic valve bioprostheses qualified for TAVI due to coexisting illnesses; Other Names: Transcatheter Aortic Valve-in-Valve Replacement (ViV-TAVR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	30 days
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))	30 days
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)	From device implant to completion of at least 2 years of follow up

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Wojciech Wojakowski, MD, PhD, Medical University of Silesia

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): May 30, 2024

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: aortic stenosis; TAVI; valve-in-valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Stenosis; Aortic Valve Insufficiency; Ventricular Outflow Obstruction
• Other Study ID Numbers: WUM-VIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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.: Yes