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 range18 Years
SexALL
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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.
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.