NCT03015194View on ClinicalTrials.gov

NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation

NACompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

June 20, 2017

Primary Completion Date

July 26, 2018

Study Completion Date

April 13, 2023

Conditions
Mitral Valve Failure
Interventions
DEVICE

Edwards SAPIEN 3 transcatheter heart valve

"Used to relieve aortic stenosis in patients with symptomatic heart disease~In this study it is not used for aortic stenosis-----the device is used in the mitral valve position."

DEVICE

ASHI INTECC Astato XS 20

"The Astato 0.014 guidewire is used for transcatheter electrosurgery in two steps in this procedure. First it is used for leaflet traversal during electrification. This procedure is similar to the use of the Astato XS20 and an amputated Asahi Confienza Pro 12 in the transcaval IDE investigation recently published. Second, the midshaft is focally denuded and electrified for the leaflet traversal step."

Trial Locations (6)

20010

Medstar Washington Hospital Center, Cardiovascular Research Program, Washington D.C.

22042

INOVA Fairfax Hospital, Falls Church

24014

Carilion Medical Center, Roanoke

48202

Henry Ford Hospital, Detroit

98195

University of Washington Division of Cardiology, Seattle

30322-1102

Emory University, Atlanta

All Listed Sponsors
lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH

NCT03015194 - NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation | Biotech Hunter | Biotech Hunter