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

Cardiac Arrhythmia Clinical Trial

Official title:
CLAIM: Using the KODEX-EPDTM System to Guide PaCing Lead Placements, A First In Man Study

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04657718
Study type Interventional
Source EPD Solutions, A Philips Company
Contact
Status Withdrawn
Phase N/A
Start date January 2021
Completion date July 2022
View Details
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