Back to resultsK2 Medical KALPA X™ Mapping, Imaging and Navigation Device
Primary Purpose
Left Atrial Appendage Aneurysm
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
KALPA X™
Sponsored by
About this trial
This is an interventional other trial for Left Atrial Appendage Aneurysm focused on measuring LAA
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Policlinico San Donato
- Vilnius University Hospital Santaros Klinikos
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KALPA X
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05155943
Brief Title
K2 Medical KALPA X™ Mapping, Imaging and Navigation Device
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
The intended population has been updated
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cara Medical Ltd
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Atrial Appendage Aneurysm
Keywords
LAA
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KALPA X
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
KALPA X™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with KALPA X™ device-related adverse events
Description
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
Time Frame
Up to 24 hours
Title
LAA maximum diameter and perimeter assessed by KALPATM compared to cardiac CT
Description
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
Time Frame
Up to 24 hours
Title
Multi-Modality Assessment of Immediate Post-LAAC Peri-Device Leak (PDL) by TEE and KALPA X™
Description
PDL measured by KALPA X™ (defined below) will be assessed compare to the PDL detected by TEE
Time Frame
Up to 24 hours
Secondary Outcome Measure Information:
Title
Follow-up PDL
Description
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
Time Frame
Up to 45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena Grinberg, PhD
Organizational Affiliation
K2 Medical
Official's Role
Study Director
Facility Information:
Facility Name
Policlinico San Donato
City
Milano
ZIP/Postal Code
20097
Country
Italy
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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K2 Medical KALPA X™ Mapping, Imaging and Navigation Device
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