18
Participants
Start Date
December 14, 2020
Primary Completion Date
February 28, 2022
Study Completion Date
October 30, 2022
KALPA X™
Before and after a transseptal puncture, the right atrium (RA), left atrial appendage (LAA), and left upper superior pulmonary vein (LUSPV) will be mapped using the KALPA™ system (WS Software ver. 1.0.229-0 Source control ID: 65f1dbf7) in combination with a commercially available catheter. Subjects will then undergo LAAC as per routine clinical care. The entire LAAC procedure will be conducted as customary practice using standard and approved off-the-shelf equipment (body surface electrodes, catheters, etc.) the operator will be blinded to the KALPA™ and KALPA X™ system information.
Policlinico San Donato, Milan
Vilnius University Hospital Santaros Klinikos, Vilnius
Lead Sponsor
Cara Medical Ltd
INDUSTRY