K2 Medical KALPA X™ Mapping, Imaging and Navigation Device

NCT05155943 | Terminated DMC

• 1 other identifier: KADILAC 1.0
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

LAA

Outcome Measures

Primary Outcomes (3)

• Number of participants with KALPA X™ device-related adverse events

  Safety of using KALPA X™ during a cardiac procedure, specifically the safety of using KALPA™ during the LAAC procedure, by collecting the records of device related AE's

  Up to 24 hours

• LAA maximum diameter and perimeter assessed by KALPATM compared to cardiac CT

  Measures of LAA maximum diameter and perimeter obtained by KALPATM performed during the LAAC procedure will be compared to these measurements obtained by the pre-procedure cardiac CT

  Up to 24 hours

• Multi-Modality Assessment of Immediate Post-LAAC Peri-Device Leak (PDL) by TEE and KALPA X™

  PDL measured by KALPA X™ (defined below) will be assessed compare to the PDL detected by TEE

  Up to 24 hours

Secondary Outcomes (1)

• Follow-up PDL

  Up to 45 days

Study Arms (1)

KALPA X

EXPERIMENTAL

The KALPA™ and KALPA X™ systems will be used during the performance of the LAAC procedure that is performed using customary and conventional tools and imaging technologies as currently performed in the participating center.

Device: KALPA X™

Interventions

KALPA X™ DEVICE

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.

KALPA X

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be ≥ 18 years of age.
• The patient meets indications for LAAC procedure.
• LAAC will be performed using the AMPLATZER Amulet device (AMPLATZER™ Amulet™ LAA Occluder, Abbott Vascular, Santa Clara, CA, USA), or, WATCHMAN (WATCHMAN™ LAAC Device or WATCHMAN FLX™ LAAC Device, Boston Scientific Marlborough, MA, USA) devices, or LAmbre LAA closure system (Lifetech Scientific Co, Ltd, Shenzhen, China), or any other LAA closure device commercially available at the discretion of the principal investigator.
• The patient is willing to comply with specified follow-up evaluations.
• The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (EC)

You may not qualify if:

• Pregnant or nursing subjects. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test.
• Patients with known atrial septal defect or atrial septal repair or closure device that would preclude transseptal puncture for LAAC.
• Patients who have a planned treatment with any other investigational device or procedure during the study period.
• Contraindications to transesophageal echocardiography (TEE), including recent esophageal or gastric surgery (within 6 months), esophageal obstruction (stricture or tumor), depressed respiratory function, active upper gastrointestinal bleeding, perforate viscous (known or suspected), or uncooperative patient.
• Contraindications to cardiac computed tomography angiography (CCTA) including pregnancy or hypersensitivity to iodinated contrast agent

Sponsors & Collaborators

• Cara Medical Ltd: lead

Study Sites (2)

Policlinico San Donato

Milan, 20097, Italy

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, 08661, Lithuania

Location

Study Officials

• Helena Grinberg, PhD

  K2 Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: December 14, 2021
• Study Start: December 14, 2020
• Primary Completion: February 28, 2022
• Study Completion: October 30, 2022
• Last Updated: February 14, 2025

Record last verified: 2021-09

Locations

LI (1); IT (1)