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

EPD Solutions

Status: Withdrawn

Conditions: Cardiac Arrhythmia

Treatments: Device: KODEX-EPD system

Study type: Interventional

Funder types: Industry

Identifiers

NCT04657718

CIPS635841

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

All subjects

Other group

Description:

The KODEX-EPD system will be used in combination with leads to image during all procedures.

Treatment:

Device: KODEX-EPD system