Left Atrial Appendage AneurysmNCT05155943
K2 Medical KALPA X™ Mapping, Imaging and Navigation Device
A study testing KALPA X™ in people with Left Atrial Appendage Aneurysm, run by Cara Medical Ltd at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Atrial Appendage Aneurysm
- What is being tested?
- KALPA X™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Dec 2020to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Lithuania1 site
Vilnius University Hospital Santaros Klinikos
Vilnius, 08661
About this study
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)
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).
Read the 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
- Being tested
- KALPA X™
- Keywords
- LAA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: KALPA X™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Up to 24 hours
Secondary outcomes (1)
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
Measured: Up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start14 Dec 2020
- Primary completion28 Feb 2022
- Study completion30 Oct 2022
Why it stopped: The intended population has been updated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Atrial Appendage AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cara Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helena Grinberg, PhD, Study director, K2 Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155943
- Sponsor's protocol ID
- KADILAC 1.0
- Status last verified
- Sep 2021
- First submitted
- 20 Sep 2021
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05155943
- Acronym / sponsor ID
- KADILAC 1.0
- Conditions
- Left Atrial Appendage Aneurysm
- Keywords
- LAA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The intended population has been updated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cara Medical LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KALPA X | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | KALPA X |
Primary outcome
Number of participants with KALPA X™ device-related adverse events
Time frame: Up to 24 hours
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
Time frame: Up to 24 hours
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™
Time frame: Up to 24 hours
PDL measured by KALPA X™ (defined below) will be assessed compare to the PDL detected by TEE
1 secondary outcome
Follow-up PDL
Time frame: Up to 45 days
Results and safety
The study was stopped early (reason given: The intended population has been updated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Grinberg, PhD study director
K2 Medical
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KALPA X™ in people with Left Atrial Appendage Aneurysm, run by Cara Medical Ltd at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The intended population has been updated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with KALPA X™ device-related adverse events (time frame: Up to 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.