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

NACompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

February 14, 2018

Primary Completion Date

September 30, 2018

Study Completion Date

August 22, 2019

Conditions
Native and Valve in Valve Aortic Valve Failure
Interventions
DEVICE

ASHI_INTECC Astato XS 20 0.014 guidewire

A coaxial traversal guiding catheter system (typically tandem catheters) directs electrosurgery devices (typically a rigid 0.014 guidewire inside a polymer jacket wire convertor) against the base of the coronary cusp targeted for laceration, using fluoroscopic and/or echocardiographic guidance. Traversal is accomplished by transcatheter electrosurgery by connecting the back end of the 0.014 guidewire to an electrosurgery pencil during short bursts of pure, cutting radiofrequency energy at ap-proximately 30W. The guidewire is repositioned as needed until it crosses the aortic leaflet and is snare-retrieved and externalized. Laceration is performed by positioning the laceration surface along the intended leaflet base, and applying tension on both free ends of the guidewire while simultaneously apply electrosurgery energy (typically 70W) in short bursts, until the laceration is complete and the guidewire is free.

Trial Locations (4)

20010

Medstar Washington Hospital Center, Washington D.C.

30322

Emory University Hospital, Atlanta

48202

Henry Ford Hospital, Detroit

98195

University of Washington, Seattle

All Listed Sponsors
lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH

NCT03381989 - Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation | Biotech Hunter | Biotech Hunter