Clinical trial NCT03381989: Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation
Official title: Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Latrogenic Coronary Artery Obstruction (BASILICA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Native and Valve in Valve Aortic Valve Failure
Keywords: TAVR
Native Aortic Valve Failure
Valve in Valve Aortic Valve Failure
TAVR Associated Coronary Artery Obstruction
Electrosurgery
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2017-12-22
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: Transcatheter aortic valve replacement (TAVR) is an option to treat aortic valve stenosis or failure of a surgically implanted tissue valve. Sometimes TAVR displaces the diseased aortic valve leaflets outwards, causing life-threatening obstruction of the coronary arteries that supply blood to the heart. This is more common in surgically implanted tissue valves that are designed to achieve the largest aortic valve orifice area. Despite attempts to protect the coronary arteries from obstruction in these patients using coronary stents, the mortality of TAVR-associated coronary artery obstruction remains prohibitively high.

The investigators have developed and tested a technique to tear the existing aortic valve leaflet and enable TAVR in such patients. The procedure is called Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA).

The purpose of this study is to perform BASILICA in patients who have no good options to prevent coronary artery obstruction during TAVR.

Eligibility criteria: * INCLUSION CRITERIA:
* Adults age greater than or equal to 21 years
* High or extreme risk of surgical aortic valve replacement according to the local multidisciplinary heart team
* Undergoing TAVR for valve-in-valve or native aortic valve failure ( on-label TAVR)
* Deemed likely to suffer coronary artery obstruction from TAVR according to multidisciplinary heart team
* Concurrence of the study eligibility committee

EXCLUSION CRITERIA:

* 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

Primary outcomes:
measure: Number of Participants With Procedure Success, Measured at Exit From the Catheterization Laboratory
timeFrame: 1 day
measure: Number of Participants Were Safety Endpoint is Freedom From Major Adverse Clinical Events (MACE)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Robert J Lederman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khan JM, Greenbaum AB, Babaliaros VC, Dvir D, Reisman M, McCabe JM, Satler L, Waksman R, Eng MH, Paone G, Chen MY, Bruce CG, Stine AM, Tian X, Rogers T, Lederman RJ. BASILICA Trial: One-Year Outcomes of Transcatheter Electrosurgical Leaflet Laceration to Prevent TAVR Coronary Obstruction. Circ Cardiovasc Interv. 2021 May;14(5):e010238. doi: 10.1161/CIRCINTERVENTIONS.120.010238. Epub 2021 May 18.