Brief Title
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - Nested Registry 3/Valve-in-Valve
Official Title
PARTNER II Nested Registry 3 (NR3)/Valve-in-Valve (ViV) is a Prospective, Single-arm, Multicenter Clinical Trial That Will Establish the Safety and Efficacy of SAPIEN XT THV in Greater-risk Patients With a Failing Aortic Bioprosthetic Valve.
Brief Summary
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients
with a failing surgical aortic bioprosthetic valve.
Detailed Description
A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a
failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or
insufficiency. This is a PARTNER II nested registry.
Study Type
Interventional
Primary Outcome
Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)
Secondary Outcome
Number of Participants With Mortality From Any Cause
Condition
Aortic Stenosis
Intervention
Edwards SAPIEN XT transcatheter valve, Model 9300TFX
Study Arms / Comparison Groups
Failing surgical valve
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
197
Start Date
June 11, 2012
Completion Date
December 16, 2020
Primary Completion Date
December 16, 2016
Eligibility Criteria
Inclusion Criteria:
1. 1.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.
2. Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA
Functional Class II or greater.
3. The heart team agreed (and verified in the case review process) that valve
implantation would likely benefit the patient.
4. 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.
5. Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.
6. Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic
position.
Exclusion Criteria:
1. Bioprosthetic valve labeled external diameter < 21mm.
2. Surgical or transcatheter valve in another position on the same side of the heart
(mitral and tricuspid rings are not an exclusion).
3. Infectious endocarditis within 6 months.
4. Acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
Gender
All
Ages
19 Years - N/A
Accepts Healthy Volunteers
No
Contacts
John Webb, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT03225001
Organization ID
2010-12 NR3/ViV
Responsible Party
Sponsor
Study Sponsor
Edwards Lifesciences
Study Sponsor
John Webb, MD, Principal Investigator, St. Paul's Hospital, Vancouver, British columbia, Canada
Verification Date
September 2019