REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Sintesi

The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).

Idoneità

Disegno dello studio

Esiti misurati

1. Esito primario

   Primary Outcome Measure

   30-day redo TAVR success defined as correct positioning of a single redo prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index (DVI) ≥0.25, aortic regurgitation (AR) \< moderate), and freedom from all-cause mortality, coronary obstruction, unplanned coronary revascularization, and surgery or intervention related to the device

   Orizzonte temporale Early (30-days)

2. Esito primario

   Primary Outcome Measure

   a composite endpoint of 1-year freedom from all-cause mortality, all stroke, or any re-hospitalization for valve or redo TAVR procedure-related causes

   Orizzonte temporale Late (1-year)

3. Esito secondario

   Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room)

   (VARC) 3 technical success (at exit from procedure room)

   Orizzonte temporale Time of procedure

4. Esito secondario

   VARC 3 30-day device success

   30-day device success

   Orizzonte temporale 30-Day

5. Esito secondario

   VARC 3 30-day early safety

   30-day early safety

   Orizzonte temporale 30-Day

6. Esito secondario

   Peak and mean invasive gradient post-procedure

   Peak and mean invasive gradient will be measured in mmHg

   Orizzonte temporale Time of procedure

7. Esito secondario

   In-hospital clinical outcomes

   Percentage of all participants with all-cause mortality, all stroke, Myocardial infarction (MI), Coronary artery obstruction, Unplanned Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG), Bleeding (VARC 3 type 1-4), Major and Minor vascular and access-related complications, Cardiac structural complications, Permanent pacemaker implantation (PPI), Acute Kidney Injury (AKI) stage 1-4, Endocarditis, and Valve Thrombosis.

   Orizzonte temporale Treatment up to 7 days (or until patient is discharged from the hospital if later than 7 days)

8. Esito secondario

   Clinical outcomes at 30 days, 1-year, and annually thereafter

   All-cause mortality, All stroke, Myocardial infarction (MI), Coronary artery obstruction, Bleeding (VARC 3 type 1-4), Major and Minor vascular and access-related complications, Cardiac structural complications, Permanent pacemaker implantation (PPI), Acute Kidney Injury (AKI) stage 1-4, Endocarditis, Valve Thrombosis, Any rehospitalization and re-intervention.

   Orizzonte temporale 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.

9. Esito secondario

   Bioprosthetic Valve Dysfunction (BVD) at the final required follow-up visit

   Intrinsic permanent changes to the prosthetic valve, including wear and tear, leaflet disruption, flail leaflet, leaflet fibrosis and/or calcification, or strut fracture or deformation

   Orizzonte temporale 5 year

10. Esito secondario

    Bioprosthetic Valve Failure (BVF) at the final required follow-up visit

    Any bioprosthetic valve dysfunction associated with clinically expressive criteria (new-onset or worsening symptoms, left ventricle dilation/hypertrophy/dysfunction, or pulmonary hypertension) or irreversible Stage 3 Hemodynamic Valve Deterioration (HVD) or Aortic valve reoperation or re-intervention, or Valve-related death.

    Orizzonte temporale Through study completion or Up to 5-years

11. Esito secondario

    Echocardiographic assessment pre-discharge or at 30 days, 1-year, and annually thereafter

    Left ventricular ejection fraction, mean gradient across aortic valve, effective orifice area, effective orifice area index, patient-prosthesis mismatch, Doppler Velocity Index, total aortic regurgitation, paravalvular aortic regurgitation, and transvalvular aortic regurgitation.

    Orizzonte temporale After the procedure and prior to discharge from the hospital, at 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.

12. Esito secondario

    Evaluate coronary accessibility (e.g., commissural alignment, valve to valve alignment, etc.) based on Computed Tomography (CT) at either pre-discharge or 30 days

    Evaluate coronary accessibility

    Orizzonte temporale Up to 30 days

13. Esito secondario

    New York Heart Association (NYHA) classification at pre-discharge, 30 days, 1-year, and annually thereafter

    New York Heart Association (NYHA) classification

    Orizzonte temporale After the procedure and prior to discharge from the hospital, at 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.

14. Esito secondario

    KCCQ Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter

    QoL: KCCQ assessment

    Orizzonte temporale At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.

15. Esito secondario

    EQ5D Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter

    QoL: EQ5D assessment

    Orizzonte temporale At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.

Date

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

71 centri stanno reclutando

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