Clinical trial NCT04657718: CLAIM: Using the KODEX-EPD System to Guide PaCing Lead Placements, A First In Man Study.
Official title: CLAIM: Using the KODEX-EPDTM System to Guide PaCing Lead Placements, A First In Man Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiac Arrhythmia
Keywords: Pacing Lead implantation
KODEX-EPD
CRT
His bundle pacing
LBBP
Lead sponsor: EPD Solutions, A Philips Company
Sponsor class: INDUSTRY
First posted: 2020-12-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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:

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.

Primary outcomes:
measure: Primary Safety Endpoint - Incidence of intra -and Perioperative complications
timeFrame: 3 months
measure: Primary Feasibility Endpoint - Ability of imaging with permanent implantable leads and guidewires.
timeFrame: time of procedure - 2-5 hours
Secondary outcomes:
measure: Right heart image
timeFrame: time of procedure - 2-5 hours
measure: Lead implantation adjusted with Fluoroscopy
timeFrame: time of procedure - 2-5 hours
measure: Fluoroscopy time
timeFrame: time of procedure - 2-5 hours
measure: Use of Contrast
timeFrame: time of procedure - 2-5 hours
measure: Procedure Time - per lead
timeFrame: time of procedure - 2-5 hours
measure: Procedure Time - all leads
timeFrame: time of procedure - 2-5 hours
measure: Total procedure time
timeFrame: time of procedure - 2-5 hours
measure: Fluoroscopy dose
timeFrame: time of procedure - 2-5 hours
Other outcomes:
Locations:
Study officials:
References: