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

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03361046
• Other study ID #: WUM-VIV
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: May 30, 2024

Study information

• Verified date: October 2020
• Source: Medical University of Warsaw
• Contact: Kajetan Grodecki
• Phone: +48660675782
• Email: kajetan.grodecki[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)
Patients with failed aortic valve bioprostheses qualified for TAVI due to coexisting illnesses

Locations

Country	Name	City	State
Poland	Medical University of Bialystok	Bialystok
Poland	Polish-American Heart Clinic	Bielsko-Biala
Poland	Medical University of Gdansk	Gdansk
Poland	Medical University of Silesia	Katowice
Poland	Jagiellonian University Medical College	Kraków
Poland	Medical University of Lodz	Lódz
Poland	Poznan University of Medical Sciences	Poznan
Poland	District Hospital 2	Rzeszów
Poland	Institute of Cardiology	Warsaw
Poland	Medical University of Warsaw	Warsaw
Poland	Wroclaw Medical University	Wroclaw
Poland	Silesian Center for Heart Diseases	Zabrze

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (4)

Huczek Z, Grodecki K, Scislo P, Wilczek K, Jagielak D, Fil W, Kubler P, Olszówka 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-valv — View Citation

Kappetein AP, Head SJ, Généreux 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, Rodés-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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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