REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

ملخص

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).

الأهلية

تصميم الدراسة

مقاييس النتائج

1. مقياس النتيجة الأولي

   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

   الإطار الزمني Early (30-days)

2. مقياس النتيجة الأولي

   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

   الإطار الزمني Late (1-year)

3. مقياس النتيجة الثانوي

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

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

   الإطار الزمني Time of procedure

4. مقياس النتيجة الثانوي

   VARC 3 30-day device success

   30-day device success

   الإطار الزمني 30-Day

5. مقياس النتيجة الثانوي

   VARC 3 30-day early safety

   30-day early safety

   الإطار الزمني 30-Day

6. مقياس النتيجة الثانوي

   Peak and mean invasive gradient post-procedure

   Peak and mean invasive gradient will be measured in mmHg

   الإطار الزمني Time of procedure

7. مقياس النتيجة الثانوي

   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.

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

8. مقياس النتيجة الثانوي

   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.

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

9. مقياس النتيجة الثانوي

   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

   الإطار الزمني 5 year

10. مقياس النتيجة الثانوي

    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.

    الإطار الزمني Through study completion or Up to 5-years

11. مقياس النتيجة الثانوي

    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.

    الإطار الزمني 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. مقياس النتيجة الثانوي

    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

    الإطار الزمني Up to 30 days

13. مقياس النتيجة الثانوي

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

    New York Heart Association (NYHA) classification

    الإطار الزمني 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. مقياس النتيجة الثانوي

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

    QoL: KCCQ assessment

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

15. مقياس النتيجة الثانوي

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

    QoL: EQ5D assessment

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

التواريخ

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المواقع

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مستندات الدراسة

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