NCT05155943

K2 Medical KALPA X™ Mapping, Imaging and Navigation Device

A Prospective, Non-randomized, Single-arm Study to Evaluate the Safety and Performance of the KALPA X™ Mapping, Imaging, and Navigation Device in Patients Undergoing Left Atrial Appendage Closure (LAAC)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Cara Medical Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, multi-center, non-randomized, single-blinded, open-label, single-arm, comparator study will enroll up to 100 eligible subjects from multiple sites undergoing LAAC procedure to evaluate the safety and performance of the KALPA™ mapping, imaging and navigation device in patients undergoing Left Atrial Appendage Closure (LAAC).

Detailed description

All subjects will undergo pre-procedural cardiac computed tomography angiography (CCTA) no more than 1 year prior to the performance of the LAAC procedure to evaluate left atrial appendage (LAA) anatomy. 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 in combination with a commercially available catheter. Subjects will then undergo LAAC as per routine clinical care. Following implantation of the LAAC device, subjects will be assessed for the peri-device leak (PDL) with a transesophageal echocardiogram (TEE) as well as PDL assessment using the KALPA X™ system (the operator will be blinded to KALPA X™ PDL reading). 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. The physician will neither use nor rely on any of the KALPA™ or KALPA X™system output for clinical decision-making. All patients will then undergo cardiac computed tomography angiography (CCTA) and TEE at 45 days following the index LAAC procedure to assess residual PDL. Intra-procedure PDL post-LAAC assessed by KALPA X™ will be compared to the detection of PDL by TEE. The value of PDL as measured by TEE compared to KALPA X™ at the time of the index LAAC procedure in predicting PDL at 45 days post-LAAC as assessed by CCTA will be compared.

Conditions

• Left Atrial Appendage Aneurysm

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-14
• Primary completion: 2022-02-28
• Completion: 2022-10-30
• First posted: 2021-12-14
• Last updated: 2025-02-14

Locations

2 sites across 2 countries: Italy, Lithuania