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

• Conditions: Aortic Valve Stenosis; Ventricular Outflow Obstruction, Left; Aortic Valve Insufficiency
• Interventions: Device: Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)

• Registration Number: NCT03361046
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-12-04
• Study Start: 2018-01-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22
• Primary Completion: 2023-12-31
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transcatheter Aortic Valve-in-Valve Implantation Cohort	Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)	-

Primary Outcome Measures

Name	Time	Method
VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint	From 30 days post procedure to completion of at least 2 years of follow up	* 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

Secondary Outcome Measures

Name	Time	Method
VARC defined 'Device success' composite endpoint	30 days	* 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)
VARC defined "Early Safety" composite endpoint	30 days	* 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))
VARC defined "Time-related valve safety" composite endpoint	From device implant to completion of at least 2 years of follow up	* 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)

Trial Locations

Locations (12)

Medical University of Bialystok; 🇵🇱 Białystok, Poland

Medical University of Silesia; 🇵🇱 Katowice, Poland

Poznan University of Medical Sciences; 🇵🇱 Poznań, Poland

District Hospital 2; 🇵🇱 Rzeszów, Poland

Medical University of Warsaw; 🇵🇱 Warsaw, Poland

Institute of Cardiology; 🇵🇱 Warsaw, Poland

Jagiellonian University Medical College; 🇵🇱 Kraków, Poland

Wroclaw Medical University; 🇵🇱 Wrocław, Poland

Silesian Center for Heart Diseases; 🇵🇱 Zabrze, Poland

Polish-American Heart Clinic; 🇵🇱 Bielsko-Biala, Poland

Medical University of Gdansk; 🇵🇱 Gdańsk, Poland

Medical University of Lodz; 🇵🇱 Łódź, Poland