NCT04657718

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: EPD Solutions, A Philips Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Arrhythmia

Interventions

Type	Name	Description
DEVICE	KODEX-EPD system	Cardiac pacing leads implantation for PM, ICD, CRT, HBP and LBBP

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2020-12-08
• Last updated: 2023-02-16

Regulatory

• FDA-regulated device study