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

Completed · Not applicable

Conditions studied: Aortic Stenosis, Cardiomyopathy, Hypertrophic

In brief

To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.

Key facts

Study ID

NCT03225001

Run by

Edwards Lifesciences

People needed

197

Starts

2012-06-11

Expected to finish

2020-10-28

Last updated by the study team

2021-03-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 D.C., 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
• Northwestern Hospital — Chicago, Illinois, United States
• NorthShore University HealthSystem Research Institute — Evanston, Illinois, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• The University of Iowa — Iowa City, Iowa, United States
• University of Louisville Jewish Hospital — Louisville, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Mayo Clinic-Saint Marys Hospital — Rochester, Minnesota, United States
• Saint Luke's Hospital of Kansas City Mid America — Kansas City, Missouri, United States
• Washington University - Barnes Jewish Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.