K2 Medical KALPA X™ Mapping, Imaging and Navigation Device

NATerminatedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

December 14, 2020

Primary Completion Date

February 28, 2022

Study Completion Date

October 30, 2022

Conditions
Left Atrial Appendage Aneurysm
Interventions
DEVICE

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.

Trial Locations (2)

20097

Policlinico San Donato, Milan

08661

Vilnius University Hospital Santaros Klinikos, Vilnius

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cara Medical Ltd

INDUSTRY

NCT05155943 - K2 Medical KALPA X™ Mapping, Imaging and Navigation Device | Biotech Hunter | Biotech Hunter