Behavior of Valve Leaflets Following Aortic Valve Implant

Completed · Not applicable

Conditions studied: Aortic-valve Replacement

In brief

This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.

Key facts

Study ID

NCT03200574

Run by

Corcym S.r.l

People needed

88

Starts

2017-12-06

Expected to finish

2021-02-25

Last updated by the study team

2024-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject has been successfully implanted with a commercially approved LivaNova bioprosthetic valve according to the instructions for use (IFU)
• The subject has signed the informed consent.
• The subject is at least 18 years of age at the time of implant and consent signature
• The subject will be available for post-operative follow-up through one year

You may not qualify if…

• The subject has a planned concomitant cardiac procedure other than coronary artery bypass graft (CABG) and septal myectomy, including MAZE procedures, atrial fibrillation surgery, and left atrial appendage exclusion or resection, or has a prosthetic heart valve or annuloplasty ring in any position
• The subject has any medical condition requiring long term (> 6 months) anticoagulation or dual antiplatelet therapy
• The subject has any clinical condition precluding the use of CT imaging with contrast
• The subject had a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days of the planned valve implant surgery
• The subject has active endocarditis, myocarditis, or sepsis
• The subject is in cardiogenic shock manifested by low cardiac output and needing hemodynamic support
• The subject is already included in another clinical trial that could confound the results of this clinical investigation

Where it is running

• St. Vincent Cardiovascular Research Institute — Indianapolis, Indiana, United States
• Maine Medical Center — Scarborough, Maine, United States
• Washington Adventist Hospital — Takoma Park, Maryland, United States
• Oakwood Hospital — Dearborn, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Missouri Baptist Hospital — St Louis, Missouri, United States
• Centennial — Nashville, Tennessee, United States
• Valley Health — Winchester, Virginia, United States
• St. Michael's Hospital — Toronto, Ontario, Canada
• Montreal Heart Institute — Montreal, Quebec, Canada
• Universite Laval — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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