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

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

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 Overview

• Status: Withdrawn
• Conditions: Cardiac Arrhythmia
• Intervention / Treatment: Device: KODEX-EPD system

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All subjects; The KODEX-EPD system will be used in combination with leads to image during all procedures.	Device: KODEX-EPD system; Cardiac pacing leads implantation for PM, ICD, CRT, HBP and LBBP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right heart image	Number of patients in whom it is possible to construct a right heart endocardial image, including visualization of right atrial appendage, tricuspidal valve, coronary sinus ostium, and coronary veins in case of CRT device implantation.	time of procedure - 2-5 hours
Lead implantation adjusted with Fluoroscopy	Number of patients in whom lead implantation needs to be fluoroscopically adjusted after KODEX-EPD-guided implantation because of 1) inability to overcome anatomical obstacles; 2) mechanical instability including spontaneous dislodgement; 3) unsatisfactorily electrical parameters.	time of procedure - 2-5 hours
Fluoroscopy time	Total fluoroscopy time	time of procedure - 2-5 hours
Use of Contrast	Total amount of contrast used, if any.	time of procedure - 2-5 hours
Procedure Time - per lead	Time to final placement, for each implanted lead (from lead introduction into sheath to final placement)	time of procedure - 2-5 hours
Procedure Time - all leads	Total lead(s) implantation time	time of procedure - 2-5 hours
Total procedure time	Total implantation time (skin-to-skin)	time of procedure - 2-5 hours
Fluoroscopy dose	Total fluoroscopy dose	time of procedure - 2-5 hours

Collaborators and Investigators

• Sponsor: EPD Solutions, A Philips Company

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: CRT; His bundle pacing; LBBP; Pacing Lead implantation; KODEX-EPD
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: CIPS635841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No