Health TrialsbyHealthPanel

Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery

ConditionsCoronary Artery DiseaseHeart Valve Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorSpectrocor

About this trial

The goal of this observational study is to test in the safety and performance of intraoperative myocardial spectroscopic measurement in open-heart surgery patients

The main questions it aims to answer are:

* The Devices can record myocardial spectrometric data for analysis, and * How these measures correlate with the occurring events, procedures, and clinical parameters during the operation. * Number of participants with device-related adverse events as assessed by CTCAE v4.0

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any 18 to 90-year-old patient scheduled for an open-heart operation

The ability to understand the study's objective and the risks involved.

Informed consent obtained, including the agreement to authorization to use the protected personal patient records according to privacy legislation.

Disqualifiers

Inability to obtain an informed consent form

Patients included as vulnerable population according to Finnish Medical Research Act, including retarded, pregnant women, nursing mothers, prisoners, or forensic patients.

Trial population

Patients scheduled for open-heart operation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Myocardial spectrometric measurement

    Device

    Myocardial spectrometric measurement during open-heart Surgery

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Myocardial spectrometric recording

Can the device record myocardial spectrometric data during open-heart surgery

Time frame
During operation
2

Measurement correlation

How the measurements correlate with the occurring events, procedures, and clinical parameters during the operation.

Time frame
During operation

Secondary outcomes

1

Adverse event assessment

Assessment of the adverse events of the device.

Time frame
From admission to discharge, up to 2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spectrocor

Lead sponsor

Source ClinicalTrials.gov
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