Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation
BASILICA
Other study identifiers
Sponsor study identifier
Secondary identifiers
interventional
31
1 country
4
Study Start
February 14, 2018
Actual (reported)Primary Completion
September 30, 2018
Actual (reported)Study Completion
August 22, 2019
Actual (reported)Brief Summary
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
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 31 participants
- Study completion date
August 22, 2019
Actual (reported)- Listed locations
- 1 countries · 4 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
December 21, 2017
Actual (reported)First Posted
December 22, 2017
Actual (reported)Study Start
February 14, 2018
Actual (reported)Primary Completion
September 30, 2018
Actual (reported)Study Completion
August 22, 2019
Actual (reported)Results Posted
March 24, 2020
Actual (reported)
- Last Updated
- March 18, 2021
- Status Verified
- September 2020
- Results QC Date
- March 10, 2020
- Last Update Submitted
- February 24, 2021