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K2 Medical KALPA X™ Mapping, Imaging and Navigation Device

NCT05155943 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-02-14

No results posted yet for this study

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).

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.

Sponsors & Collaborators

  • Cara Medical Ltd

    lead INDUSTRY

Principal Investigators

  • Helena Grinberg, PhD · K2 Medical

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2022-02-28
Completion
2022-10-30

Countries

  • Italy
  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05155943 on ClinicalTrials.gov