Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation

Completed · Not applicable

Conditions studied: Native and Valve in Valve Aortic Valve Failure

In brief

Background: TAVR is a common therapy for people with heart problems. It stands for transcatheter aortic valve replacement, TAVR can be a better option than surgery. But it isn t safe for everyone. It may block the arteries that supply blood to the heart muscle by pushing heart valve tissue outward. Researchers want to study a method that may make TAVR safer. It is known as Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA). Objective: To study the feasibility and safety of BASILICA in people at high risk of coronary artery obstruction that complicates TAVR. Eligibility: People at least 21 years old whose heart doctors do not think they can have TAVR safely Design: Participants will be screened by a team of heart specialists. They will have heart and blood tests. They will answer questions. Participants will have TAVR using BASILICA. They will get general anesthesia or they will be sedated. While using x-rays and echocardiography, doctors will cross and split the aortic valve leaflet using an electrified wire. A standard TAVR valve will be implanted. After the procedure, participants will have blood tests and physical exams. They will answer questions. They will have heart tests. Participants will have a scan within 1 month and after 12 months. They will have heart tests during follow-up visits in the first year. Sponsoring Institute: National Heart, Lung and Blood Institute

Key facts

Study ID

NCT03381989

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

31

Starts

2018-02-14

Expected to finish

2019-08-22

Last updated by the study team

2021-03-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects unable to consent to participate, unless the subject has a legally authorized representative
• Excessive target aortic leaflet calcification or masses on baseline CT
• Survival despite successful procedure expected < 12 months
• Planned concurrent valve intervention in the same setting (such as transcatheter mitral valve therapy or paravalvular leak therapy)
• Subjects unwilling to participate or unwilling to return for study follow-up activities.
• Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures

Where it is running

• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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