Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06777368

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

Primary Objectives:

  • To determine the acute and long-term outcomes of redo TAVR for the treatment of BVF affecting TAVs
  • To determine the factors which are associated with the acute and long-term outcomes of redo TAVR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR

Exclusion criteria

  • BVF due solely to paravalvular regurgitation
  • Active endocarditis
  • Untreated acute valve thrombosis
  • Life-expectancy less than 1-year
  • Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
  • Participating in another study that may influence the outcome of this study

Treatment and study plan

Medtronic TAV

Device

Medtronic TAV where commercially available

Edwards TAV

Device

Edwards TAV where commercially available.

Primary outcomes

  1. Primary Outcome Measure

    Time frame: Early (30-days)

    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

  2. Primary Outcome Measure

    Time frame: Late (1-year)

    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

Secondary outcomes

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

    Time frame: Time of procedure

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

  2. VARC 3 30-day device success

    Time frame: 30-Day

    30-day device success

  3. VARC 3 30-day early safety

    Time frame: 30-Day

    30-day early safety

  4. Peak and mean invasive gradient post-procedure

    Time frame: Time of procedure

    Peak and mean invasive gradient will be measured in mmHg

  5. In-hospital clinical outcomes

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

    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.

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

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

    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.

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

    Time frame: 5 year

    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

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

    Time frame: Through study completion or Up to 5-years

    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.

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

    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.

    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.

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

    Time frame: Up to 30 days

    Evaluate coronary accessibility

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

    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.

    New York Heart Association (NYHA) classification

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

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

    QoL: KCCQ assessment

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

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

    QoL: EQ5D assessment

Study contacts

Contact information is provided by the study sponsor or research team.

RESTORE Study Clinical Team

CONTACT

[email protected]

763 514 4000

Sponsors and collaborators

Lead sponsor

Medtronic Cardiovascular

Industry

Registry information

Acronym: RESTORE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 15, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.