PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve

Not Applicable

Completed

• Conditions: Cardiomyopathy, Hypertrophic; Aortic Stenosis

• Registration Number: NCT03225001
• Lead Sponsor: Edwards Lifesciences

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 Timeline

• Study Start: 2012-06-11
• Primary Completion: 2016-12-16
• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Results First Submitted: 2017-12-07
• Results First Submitted QC: 2017-12-07
• Results First Posted: 2018-01-09
• Study Completion: 2020-10-28
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

Inclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)	30-day	The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Mortality From Any Cause	30 Days	Cardiovascular cause is also included

Trial Locations

Locations (47)

Scripps Green Hospital; 🇺🇸 La Jolla, California, United States

Scripps Memorial Hospital; 🇺🇸 La Jolla, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Mercy General Hospital; 🇺🇸 Sacramento, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

University of Colorado Hospital; 🇺🇸 Denver, Colorado, United States

Washington Hospital Center (WHC); 🇺🇸 Washington, District of Columbia, United States

Morton Plant Hospital; 🇺🇸 Clearwater, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

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