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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Left Atrial Appendage Aneurysm
• Intervention / Treatment: Device: KALPA X™

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20097
    • Policlínico San Donato
• Lithuania
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santaros Klinikos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The patient must be ≥ 18 years of age.
2. The patient meets indications for LAAC procedure.
3. 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.
4. The patient is willing to comply with specified follow-up evaluations.
5. 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)

Exclusion Criteria:

1. 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.
2. Patients with known atrial septal defect or atrial septal repair or closure device that would preclude transseptal puncture for LAAC.
3. Patients who have a planned treatment with any other investigational device or procedure during the study period.
4. 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.
5. Contraindications to cardiac computed tomography angiography (CCTA) including pregnancy or hypersensitivity to iodinated contrast agent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: KALPA X; 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™; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follow-up PDL	The predictive power of intra-procedural TEE and KALPA X™ for the detection of PDL will be compared to 45 day post-LAAC PDL as detected by TEE and CCTA	Up to 45 days

Collaborators and Investigators

• Sponsor: K2 Medical Ltd
• Investigators: Study Director: Helena Grinberg, PhD, K2 Medical

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2020
• Primary Completion (ANTICIPATED): October 31, 2022
• Study Completion (ANTICIPATED): December 30, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (ACTUAL): December 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: LAA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: KADILAC 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No