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

Cardiac Arrhythmia Clinical Trial

— CLAIM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04657718
• Other study ID #: CIPS635841
• Status: Withdrawn
• Phase: N/A
• Start date: January 2021
• Est. completion date: July 2022

Study information

• Verified date: June 2020
• Source: EPD Solutions, A Philips Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Device:
• KODEX-EPD system
Cardiac pacing leads implantation for PM, ICD, CRT, HBP and LBBP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EPD Solutions, A Philips Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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
Secondary	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
Secondary	Fluoroscopy time	Total fluoroscopy time	time of procedure - 2-5 hours
Secondary	Use of Contrast	Total amount of contrast used, if any.	time of procedure - 2-5 hours
Secondary	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
Secondary	Procedure Time - all leads	Total lead(s) implantation time	time of procedure - 2-5 hours
Secondary	Total procedure time	Total implantation time (skin-to-skin)	time of procedure - 2-5 hours
Secondary	Fluoroscopy dose	Total fluoroscopy dose	time of procedure - 2-5 hours