PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve (PII NR3/ViV)
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|ClinicalTrials.gov Identifier: NCT03225001|
Recruitment Status : Completed
First Posted : July 21, 2017
Results First Posted : January 9, 2018
Last Update Posted : March 9, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Aortic Stenosis Cardiomyopathy, Hypertrophic||Device: Edwards SAPIEN XT transcatheter valve, Model 9300TFX||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||197 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Patients With a Failing Aortic Bioprosthetic Valve|
|Actual Study Start Date :||June 11, 2012|
|Actual Primary Completion Date :||December 16, 2016|
|Actual Study Completion Date :||October 28, 2020|
Experimental: Failing surgical valve
Patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.
Device: Edwards SAPIEN XT transcatheter valve, Model 9300TFX
Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.
Other Name: TAVI
- Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite) [ Time Frame: 30-day ]The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak
- Number of Participants With Mortality From Any Cause [ Time Frame: 30 Days ]Cardiovascular cause is also included
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA < 0.5 cm2/m2. Qualifying echo must be within 60 days of the date of the procedure.
- Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
- The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
- The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.
- Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic position.
- Bioprosthetic valve labeled external diameter < 21mm.
- Surgical or transcatheter valve in another position on the same side of the heart (mitral and tricuspid rings are not an exclusion).
- Infectious endocarditis within 6 months.
- Acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225001
|Principal Investigator:||John Webb, MD||St. Paul's Hospital, Vancouver, British columbia, Canada|
|Principal Investigator:||Michael Mack, MD||Baylor Heart Hospital, Plano, TX|
|Responsible Party:||Edwards Lifesciences|
|Other Study ID Numbers:||
|First Posted:||July 21, 2017 Key Record Dates|
|Results First Posted:||January 9, 2018|
|Last Update Posted:||March 9, 2021|
|Last Verified:||February 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
failing surgical valve
failing bioprosthetic valve
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
Ventricular Outflow Obstruction
Aortic Stenosis, Subvalvular