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

NCT04657718 | Withdrawn DMC FDA Device

• 1 other identifier: CIPS635841
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective, multi-center (2-3 sites), non-randomized, open label, single arm 3 phase study:

• 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

Keywords

Pacing Lead implantation; KODEX-EPD; CRT; His bundle pacing; LBBP

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  time of procedure - 2-5 hours

Secondary Outcomes (8)

• Right heart image

  time of procedure - 2-5 hours

• Lead implantation adjusted with Fluoroscopy

  time of procedure - 2-5 hours

• Fluoroscopy time

  time of procedure - 2-5 hours

• Use of Contrast

  time of procedure - 2-5 hours

• Procedure Time - per lead

  time of procedure - 2-5 hours

Study Arms (1)

All subjects

OTHER

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

Device: KODEX-EPD system

Interventions

KODEX-EPD system DEVICE

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

All subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be aged \>18 years.
• Subject must have signed a written iInformed Cconsent form to participate in the study, prior to any study related procedures.
• Subject must be willing to comply with the protocol requirements.
• Subject is scheduled for a de novo pacing lead implantation or system upgrade .

You may not qualify if:

• Patients for whom previous CRT or conduction pacing implantation has failed.
• Patients considered for leadless cardiac pacing system.
• Patients undergoing a system revision for infection or malfunction.
• Patients undergoing planned, urgent or emergency lead revision or lead extraction.
• 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.
• Patients included in a clinical registry or clinical trial for an investigational product.
• Pregnant women.

Sponsors & Collaborators

• EPD Solutions, A Philips Company: lead

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 8, 2020
• Study Start: January 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: February 16, 2023

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share