NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery

RecruitingN/A

Sponsor: Spectrocor

Conditions: Coronary Artery Disease, Heart Valve Diseases

Interventions: Myocardial spectrometric measurement

Countries: Finland

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 overview

Sex: ALL

Age: 18 Years to 90 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

Helsinki, Uusimaa, Finland