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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2022-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Arrhythmia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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All subjects

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

Group Type OTHER

KODEX-EPD system

Intervention Type DEVICE

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

Interventions

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KODEX-EPD system

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No