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

EPD Solutions, A Philips Company

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Conditions

Cardiac Arrhythmia

Interventions

KODEX-EPD systemDEVICE

Cardiac pacing leads implantation for PM, ICD, CRT, HBP and LBBP

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Primary Safety Endpoint - Incidence of intra -and Perioperative complications

Incidence rate of intra -and Perioperative complications (bleeding, hematoma, cardiac tamponade, cardiac perforation , appearance of hemodynamic relevant arrhythmias requiring intervention)

Time frame: 3 months

Primary Feasibility Endpoint - Ability of imaging with permanent implantable leads and guidewires.

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.