REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Summary

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).

Eligibility

Study design

Outcome measures

1. Primary outcome

   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

   Time frame Early (30-days)

2. Primary outcome

   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

   Time frame Late (1-year)

3. Secondary outcome

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

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

   Time frame Time of procedure

4. Secondary outcome

   VARC 3 30-day device success

   30-day device success

   Time frame 30-Day

5. Secondary outcome

   VARC 3 30-day early safety

   30-day early safety

   Time frame 30-Day

6. Secondary outcome

   Peak and mean invasive gradient post-procedure

   Peak and mean invasive gradient will be measured in mmHg

   Time frame Time of procedure

7. Secondary outcome

   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.

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

8. Secondary outcome

   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.

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

9. Secondary outcome

   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

   Time frame 5 year

10. Secondary outcome

    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.

    Time frame Through study completion or Up to 5-years

11. Secondary outcome

    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.

    Time frame 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. Secondary outcome

    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

    Time frame Up to 30 days

13. Secondary outcome

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

    New York Heart Association (NYHA) classification

    Time frame 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. Secondary outcome

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

    QoL: KCCQ assessment

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

15. Secondary outcome

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

    QoL: EQ5D assessment

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

Dates

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

71 sites are recruiting

21 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.