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

Not Applicable

Withdrawn

• Conditions: Cardiac Arrhythmia
• Interventions: Device: KODEX-EPD system

• Registration Number: NCT04657718
• Lead Sponsor: EPD Solutions, A Philips Company

Brief 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. 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

3. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-08
• Study Start: 2021-01
• Primary Completion: 2022-07
• Study Completion: 2022-07
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subject must be aged >18 years.
2. Subject must have signed a written iInformed Cconsent form to participate in the study, prior to any study related procedures.
3. Subject must be willing to comply with the protocol requirements.
4. Subject is scheduled for a de novo pacing lead implantation or system upgrade .

Exclusion Criteria

1. Patients for whom previous CRT or conduction pacing implantation has failed.
2. Patients considered for leadless cardiac pacing system.
3. Patients undergoing a system revision for infection or malfunction.
4. Patients undergoing planned, urgent or emergency lead revision or lead extraction.
5. 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.
6. Patients included in a clinical registry or clinical trial for an investigational product.
7. Pregnant women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	KODEX-EPD system	The KODEX-EPD system will be used in combination with leads to image during all procedures.

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint - Incidence of intra -and Perioperative complications	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 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.

Secondary Outcome Measures

Name	Time	Method
Use of Contrast	time of procedure - 2-5 hours	Total amount of contrast used, if any.
Procedure Time - per lead	time of procedure - 2-5 hours	Time to final placement, for each implanted lead (from lead introduction into sheath to final placement)
Total procedure time	time of procedure - 2-5 hours	Total implantation time (skin-to-skin)
Lead implantation adjusted with Fluoroscopy	time of procedure - 2-5 hours	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.
Fluoroscopy dose	time of procedure - 2-5 hours	Total fluoroscopy dose
Procedure Time - all leads	time of procedure - 2-5 hours	Total lead(s) implantation time
Right heart image	time of procedure - 2-5 hours	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.
Fluoroscopy time	time of procedure - 2-5 hours	Total fluoroscopy time