REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

תקציר

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).

זכאות

תכנון המחקר

מדדי תוצאה

1. מדד תוצאה ראשוני

   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

   מסגרת זמן Early (30-days)

2. מדד תוצאה ראשוני

   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

   מסגרת זמן Late (1-year)

3. מדד תוצאה משני

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

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

   מסגרת זמן Time of procedure

4. מדד תוצאה משני

   VARC 3 30-day device success

   30-day device success

   מסגרת זמן 30-Day

5. מדד תוצאה משני

   VARC 3 30-day early safety

   30-day early safety

   מסגרת זמן 30-Day

6. מדד תוצאה משני

   Peak and mean invasive gradient post-procedure

   Peak and mean invasive gradient will be measured in mmHg

   מסגרת זמן Time of procedure

7. מדד תוצאה משני

   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.

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

8. מדד תוצאה משני

   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.

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

9. מדד תוצאה משני

   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

   מסגרת זמן 5 year

10. מדד תוצאה משני

    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.

    מסגרת זמן Through study completion or Up to 5-years

11. מדד תוצאה משני

    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.

    מסגרת זמן 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. מדד תוצאה משני

    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

    מסגרת זמן Up to 30 days

13. מדד תוצאה משני

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

    New York Heart Association (NYHA) classification

    מסגרת זמן 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. מדד תוצאה משני

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

    QoL: KCCQ assessment

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

15. מדד תוצאה משני

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

    QoL: EQ5D assessment

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

תאריכים

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

71 אתרים מגייסים

21 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

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