REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Zusammenfassung

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).

Eignung

Studiendesign

Endpunkte

1. Primärer Endpunkt

   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

   Zeitrahmen Early (30-days)

2. Primärer Endpunkt

   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

   Zeitrahmen Late (1-year)

3. Sekundärer Endpunkt

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

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

   Zeitrahmen Time of procedure

4. Sekundärer Endpunkt

   VARC 3 30-day device success

   30-day device success

   Zeitrahmen 30-Day

5. Sekundärer Endpunkt

   VARC 3 30-day early safety

   30-day early safety

   Zeitrahmen 30-Day

6. Sekundärer Endpunkt

   Peak and mean invasive gradient post-procedure

   Peak and mean invasive gradient will be measured in mmHg

   Zeitrahmen Time of procedure

7. Sekundärer Endpunkt

   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.

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

8. Sekundärer Endpunkt

   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.

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

9. Sekundärer Endpunkt

   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

   Zeitrahmen 5 year

10. Sekundärer Endpunkt

    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.

    Zeitrahmen Through study completion or Up to 5-years

11. Sekundärer Endpunkt

    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.

    Zeitrahmen 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. Sekundärer Endpunkt

    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

    Zeitrahmen Up to 30 days

13. Sekundärer Endpunkt

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

    New York Heart Association (NYHA) classification

    Zeitrahmen 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. Sekundärer Endpunkt

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

    QoL: KCCQ assessment

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

15. Sekundärer Endpunkt

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

    QoL: EQ5D assessment

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

Daten

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

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