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Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery

RECRUITINGSponsored by Spectrocor
Actively Recruiting
SponsorSpectrocor
Started2023-10-06
Est. completion2026-12-31
Eligibility
Age18 Years – 90 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06084091

Summary

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

Age: 18 Years – 90 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Conditions3

Coronary Artery DiseaseHeart DiseaseHeart Valve Diseases

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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