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

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ClinicalTrials.gov Identifier: NCT03361046
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

Tracking Information
First Submitted Date November 28, 2017
First Posted Date December 4, 2017
Last Update Posted Date March 20, 2018
Actual Study Start Date January 1, 2018
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2018)
VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint [ Time Frame: 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
Original Primary Outcome Measures
 (submitted: November 28, 2017)
VARC defined "Clinical Efficacy" composite endpoint [ Time Frame: 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
Change History Complete list of historical versions of study NCT03361046 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 29, 2018)
  • VARC defined 'Device success' composite endpoint [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)
Original Secondary Outcome Measures
 (submitted: November 28, 2017)
  • VARC defined 'Device success' composite endpoint [ Time Frame: 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 mismatcha 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 [ Time Frame: 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 [ Time Frame: 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Aortic Valve Stenosis
  • Aortic Valve Insufficiency
  • 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
Other Name: Transcatheter Aortic Valve-in-Valve Replacement (ViV-TAVR)
Study Groups/Cohorts Transcatheter Aortic Valve-in-Valve Implantation Cohort
Intervention: Device: Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 28, 2017)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 30, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kajetan Grodecki +48660675782 kajetan.grodecki@gmail.com
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03361046
Other Study ID Numbers WUM-VIV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Medical University of Warsaw
Study Sponsor Medical University of Warsaw
Collaborators Not Provided
Investigators
Principal Investigator: Zenon Huczek, MD, PhD Medical University of Warsaw
Principal Investigator: Wojciech Wojakowski, MD, PhD Medical University of Silesia
PRS Account Medical University of Warsaw
Verification Date July 2017