Cardiac ArrhythmiaCLAIMNCT04657718
CLAIM: Using the KODEX-EPD System to Guide PaCing Lead Placements, A First In Man Study.
A study testing KODEX-EPD system in people with Cardiac Arrhythmia, run by EPD Solutions, A Philips Company.
Trial summary
Prospective, multi-center (2-3 sites), non-randomized, open label, single arm 3 phase study: 1. Phase 1 or Evaluation Phase: Where the KODEX-EPD System will be used to exclusively monitor the entire implantation procedure; the KODEX-EPD system will not be used for guidance during the lead implantation workflow. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- KODEX-EPD system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jul 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
- Subject must be aged >18 years.
- Subject must have signed a written iInformed Cconsent form to participate in the study, prior to any study related procedures.
- Subject must be willing to comply with the protocol requirements.
- Subject is scheduled for a de novo pacing lead implantation or system upgrade .
Who cannot join
- Patients for whom previous CRT or conduction pacing implantation has failed.
- Patients considered for leadless cardiac pacing system.
- Patients undergoing a system revision for infection or malfunction.
- Patients undergoing planned, urgent or emergency lead revision or lead extraction.
- Subjects who have received or will receive an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.
- Patients included in a clinical registry or clinical trial for an investigational product.
- Pregnant women.
About this study
Official title: CLAIM: Using the KODEX-EPDTM System to Guide PaCing Lead Placements, A First In Man Study
Prospective, multi-center (2-3 sites), non-randomized, open label, single arm 3 phase study:
- Phase 1 or Evaluation Phase: Where the KODEX-EPD System will be used to exclusively monitor the entire implantation procedure; the KODEX-EPD system will not be used for guidance during the lead implantation workflow.
- Phase 2 - KODEX-EPD-assisted Phase: Where the KODEX-EPD system will be used for cardiac imaging acquisition, guidance during lead implantation in conjunction with fluoroscopic imaging
- Phase 3 - KODEX-EPD-guided Phase: Where the KODEX_EPD System will be used as the leading imaging modality during the lead implantation workflow. Fluoro can be used;
- up until the part of the lead implantation workflow that is the scope of this investigation.
- As a bailout, when the operator declares failure to attempt.
- Conditions
- Cardiac Arrhythmia
- Being tested
- KODEX-EPD system
- Keywords
- Pacing Lead implantation, KODEX-EPD, CRT, His bundle pacing, LBBP
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KODEX-EPD systemDevice
Cardiac pacing leads implantation for PM, ICD, CRT, HBP and LBBP
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Other | The KODEX-EPD system will be used in combination with leads to image during all procedures. Receives: Device: KODEX-EPD system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint - Incidence of intra -and Perioperative complications
Incidence rate of intra -and Perioperative complications (bleeding, hematoma, cardiac tamponade, cardiac perforation , appearance of hemodynamic relevant arrhythmias requiring intervention)
Measured: 3 months
Primary Feasibility Endpoint - Ability of imaging with permanent implantable leads and guidewires.
The successful use of permanent implantable leads and guidewires for imaging with KODEX - EPD. Assessment of the ability of the KODEX-EPD system to create real time 3D images of the anatomy of the heart.
Measured: time of procedure - 2-5 hours
Secondary outcomes (8)
Right heart image
Number of patients in whom it is possible to construct a right heart endocardial image, including visualization of right atrial appendage, tricuspidal valve, coronary sinus ostium, and coronary veins in case of CRT device implantation.
Measured: time of procedure - 2-5 hours
Lead implantation adjusted with Fluoroscopy
Number of patients in whom lead implantation needs to be fluoroscopically adjusted after KODEX-EPD-guided implantation because of 1) inability to overcome anatomical obstacles; 2) mechanical instability including spontaneous dislodgement; 3) unsatisfactorily electrical parameters.
Measured: time of procedure - 2-5 hours
Fluoroscopy time
Total fluoroscopy time
Measured: time of procedure - 2-5 hours
Use of Contrast
Total amount of contrast used, if any.
Measured: time of procedure - 2-5 hours
Procedure Time - per lead
Time to final placement, for each implanted lead (from lead introduction into sheath to final placement)
Measured: time of procedure - 2-5 hours
Procedure Time - all leads
Total lead(s) implantation time
Measured: time of procedure - 2-5 hours
Total procedure time
Total implantation time (skin-to-skin)
Measured: time of procedure - 2-5 hours
Fluoroscopy dose
Total fluoroscopy dose
Measured: time of procedure - 2-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: Study never started - clinical strategy changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EPD Solutions, A Philips Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657718
- Sponsor's protocol ID
- CIPS635841
- Acronym
- CLAIM
- Status last verified
- Jun 2020
- First submitted
- 17 Nov 2020
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLAIM: Using the KODEX-EPDTM System to Guide PaCing Lead Placements, A First In Man Study
- ClinicalTrials.gov ID
- NCT04657718
- Acronym / sponsor ID
- CLAIM / CIPS635841
- Conditions
- Cardiac Arrhythmia
- Keywords
- Pacing Lead implantation, KODEX-EPD, CRT, His bundle pacing, LBBP
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started - clinical strategy changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EPD Solutions, A Philips CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 8 Dec 2020 (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.
Prospective, multi-center (2-3 sites), non-randomized, open label, single arm 3 phase study:
- Phase 1 or Evaluation Phase: Where the KODEX-EPD System will be used to exclusively monitor the entire implantation procedure; the KODEX-EPD system will not be used for guidance during the lead implantation workflow.
- Phase 2 - KODEX-EPD-assisted Phase: Where the KODEX-EPD system will be used for cardiac imaging acquisition, guidance during lead implantation in conjunction with fluoroscopic imaging
- Phase 3 - KODEX-EPD-guided Phase: Where the KODEX_EPD System will be used as the leading imaging modality during the lead implantation workflow. Fluoro can be used;
- up until the part of the lead implantation workflow that is the scope of this investigation.
- As a bailout, when the operator declares failure to attempt.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Other | Device: KODEX-EPD systemThe KODEX-EPD system will be used in combination with leads to image during all procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must be aged >18 years.
- Subject must have signed a written iInformed Cconsent form to participate in the study, prior to any study related procedures.
- Subject must be willing to comply with the protocol requirements.
- Subject is scheduled for a de novo pacing lead implantation or system upgrade .
Key exclusion criteria (7 listed)
- Patients for whom previous CRT or conduction pacing implantation has failed.
- Patients considered for leadless cardiac pacing system.
- Patients undergoing a system revision for infection or malfunction.
- Patients undergoing planned, urgent or emergency lead revision or lead extraction.
- Subjects who have received or will receive an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.
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 |
|---|---|---|
| KODEX-EPD systemCardiac pacing leads implantation for PM, ICD, CRT, HBP and LBBP | Device | All subjects |
Primary outcome
Primary Safety Endpoint - Incidence of intra -and Perioperative complications
Time frame: 3 months
Incidence rate of intra -and Perioperative complications (bleeding, hematoma, cardiac tamponade, cardiac perforation , appearance of hemodynamic relevant arrhythmias requiring intervention)
Primary Feasibility Endpoint - Ability of imaging with permanent implantable leads and guidewires.
Time frame: time of procedure - 2-5 hours
The successful use of permanent implantable leads and guidewires for imaging with KODEX - EPD. Assessment of the ability of the KODEX-EPD system to create real time 3D images of the anatomy of the heart.
8 secondary outcomes
Right heart image
Time frame: time of procedure - 2-5 hours
Lead implantation adjusted with Fluoroscopy
Time frame: time of procedure - 2-5 hours
Fluoroscopy time
Time frame: time of procedure - 2-5 hours
Use of Contrast
Time frame: time of procedure - 2-5 hours
Procedure Time - per lead
Time frame: time of procedure - 2-5 hours
Procedure Time - all leads
Time frame: time of procedure - 2-5 hours
Total procedure time
Time frame: time of procedure - 2-5 hours
Fluoroscopy dose
Time frame: time of procedure - 2-5 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing KODEX-EPD system in people with Cardiac Arrhythmia, run by EPD Solutions, A Philips Company.
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Primary Safety Endpoint - Incidence of intra -and Perioperative complications (time frame: 3 months). The study lists 2 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 16 Feb 2023.