Brief 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).
Brief Title
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
Detailed Description
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
* 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
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
763 514 4000
Central Contact Email
RS.RESTORESTUDY@medtronic.com
Completion Date
Completion Date Type
Estimated
Conditions
Aortic Stenosis
Eligibility Criteria
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
* 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
Inclusion Criteria
Inclusion Criteria:
* BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR
* BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
105 Years
Minimum Age
18 Years
NCT Id
NCT06777368
Org Class
Industry
Org Full Name
Medtronic Cardiovascular
Org Study Id
MDT23040EVR015
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
Primary Outcomes
Outcome Description
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
Outcome Measure
Primary Outcome Measure
Outcome Time Frame
Early (30-days)
Outcome Description
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
Outcome Measure
Primary Outcome Measure
Outcome Time Frame
Late (1-year)
Secondary Outcomes
Outcome Description
(VARC) 3 technical success (at exit from procedure room)
Outcome Time Frame
Time of procedure
Outcome Measure
Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room)
Outcome Description
30-day device success
Outcome Time Frame
30-Day
Outcome Measure
VARC 3 30-day device success
Outcome Description
30-day early safety
Outcome Time Frame
30-Day
Outcome Measure
VARC 3 30-day early safety
Outcome Description
Peak and mean invasive gradient will be measured in mmHg
Outcome Time Frame
Time of procedure
Outcome Measure
Peak and mean invasive gradient post-procedure
Outcome Description
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.
Outcome Time Frame
Treatment up to 7 days (or until patient is discharged from the hospital if later than 7 days)
Outcome Measure
In-hospital clinical outcomes
Outcome Description
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.
Outcome Time Frame
30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
Outcome Measure
Clinical outcomes at 30 days, 1-year, and annually thereafter
Outcome Description
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
Outcome Time Frame
5 year
Outcome Measure
Bioprosthetic Valve Dysfunction (BVD) at the final required follow-up visit
Outcome Description
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.
Outcome Time Frame
Through study completion or Up to 5-years
Outcome Measure
Bioprosthetic Valve Failure (BVF) at the final required follow-up visit
Outcome Description
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.
Outcome 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.
Outcome Measure
Echocardiographic assessment pre-discharge or at 30 days, 1-year, and annually thereafter
Outcome Description
Evaluate coronary accessibility
Outcome Time Frame
Up to 30 days
Outcome Measure
Evaluate coronary accessibility (e.g., commissural alignment, valve to valve alignment, etc.) based on Computed Tomography (CT) at either pre-discharge or 30 days
Outcome Description
New York Heart Association (NYHA) classification
Outcome 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.
Outcome Measure
New York Heart Association (NYHA) classification at pre-discharge, 30 days, 1-year, and annually thereafter
Outcome Description
QoL: KCCQ assessment
Outcome Time Frame
At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
Outcome Measure
KCCQ Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter
Outcome Description
QoL: EQ5D assessment
Outcome Time Frame
At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
Outcome Measure
EQ5D Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
The study population includes patients with symptomatic heart disease due to BVF affecting TAVs and requiring redo TAVR.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
105
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mohamed Azeem Latib
Investigator Email
mlatib@montefiore.org
Investigator Phone
646-773-2076