Clinical trial NCT03361046: Polish Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI) Registry
Official title: Evaluation of Clinical Outcomes of Transcatheter Aortic Valve-in-Valve Implantation in Polish Population - Observational Multicenter Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Aortic Valve Insufficiency
Ventricular Outflow Obstruction, Left
Keywords: TAVI
valve-in-valve
aortic stenosis
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint
timeFrame: From 30 days post procedure to completion of at least 2 years of follow up
Secondary outcomes:
measure: VARC defined 'Device success' composite endpoint
timeFrame: 30 days
measure: VARC defined "Early Safety" composite endpoint
timeFrame: 30 days
measure: VARC defined "Time-related valve safety" composite endpoint
timeFrame: From device implant to completion of at least 2 years of follow up
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Medical University of Bialystok
city: Bielsko-Biala
country: Poland
facility: Polish-American Heart Clinic
city: Gdańsk
country: Poland
facility: Medical University of Gdansk
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Kraków
country: Poland
facility: Jagiellonian University Medical College
city: Poznań
country: Poland
facility: Poznan University of Medical Sciences
city: Rzeszów
country: Poland
facility: District Hospital 2
city: Warsaw
country: Poland
facility: Institute of Cardiology
city: Warsaw
country: Poland
facility: Medical University of Warsaw
city: Wrocław
country: Poland
facility: Wroclaw Medical University
city: Zabrze
country: Poland
facility: Silesian Center for Heart Diseases
city: Łódź
country: Poland
facility: Medical University of Lodz
Study officials:
affiliation: Medical University of Warsaw
name: Zenon Huczek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Silesia
name: Wojciech Wojakowski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.