CLAIM: Using the KODEX-EPD System to Guide PaCing Lead Placements, A First In Man Study. (NCT04657718) | Clinical Trial Compass
WithdrawnNot Applicable
CLAIM: Using the KODEX-EPD System to Guide PaCing Lead Placements, A First In Man Study.
Stopped: Study never started - clinical strategy changed
0Started 2021-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Safety Endpoint - Incidence of intra -and Perioperative complications
Timeframe: 3 months
2
Primary Feasibility Endpoint - Ability of imaging with permanent implantable leads and guidewires.
. 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.