CLAIM: Using the KODEX-EPD System to Guide PaCing Lead Placements, A First In Man Study.

Study Overview
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Brief Summary
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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.

Official Title
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CLAIM: Using the KODEX-EPDTM System to Guide PaCing Lead Placements, A First In Man Study

Conditions
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Cardiac Arrhythmia

Intervention / Treatment
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* Device: KODEX-EPD system


Participation Criteria
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Eligibility Criteria
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Patients scheduled to undergo lead placement for cardiac pacing. Subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study. Inclusion Criteria: 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 . Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All subjects<br>The KODEX-EPD system will be used in combination with leads to image during all procedures. | Device: KODEX-EPD system<br>* Cardiac pacing leads implantation for PM, ICD, CRT, HBP and LBBP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | time of procedure - 2-5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | time of procedure - 2-5 hours | 
| Fluoroscopy time | Total fluoroscopy time | time of procedure - 2-5 hours | 
| Use of Contrast | Total amount of contrast used, if any. | 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) | time of procedure - 2-5 hours | 
| Procedure Time - all leads | Total lead(s) implantation time | time of procedure - 2-5 hours | 
| Total procedure time | Total implantation time (skin-to-skin) | time of procedure - 2-5 hours | 
| Fluoroscopy dose | Total fluoroscopy dose | time of procedure - 2-5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacing Lead implantation, KODEX-EPD, CRT, His bundle pacing, LBBP