An observational study in Transcatheter Aortic Valve Implantation, Dental and Endocarditis, sponsored by Odense University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Odense University Hospital · Observational
In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with Transcatheter Aortic Valve Implantation (TAVI) was changed from mandatory to targeted PDS to between June 2023 to october 2023. The investigators will therefore compare the risk of IE before june 2023 and after october 2023.
Infective endocarditis (IE), a condition linked with significant mortality and morbidity rates, is particularly concerning for patients with prosthetic left-sided valves.
These patients face an elevated IE risk, estimated at about 1% annually in tertiary care settings, cumulatively impacting around one in every 20 patients over a decade.
In line with this, both the American Heart Association (AHA) and the European Society of Cardiology (ESC) strongly advocate for the elimination of potential dental sepsis sources at least two weeks before prosthetic valve implantation, except in urgent cases.
These guidelines, while not grounded in randomized trials, largely draw upon registry data detailing IE incidence among surgical aortic valve replacement (SAVR) patients.
In a recent study the investigators found no difference in risk of IE when comparing mandatory preoperative dental screening (MPDS) with no preoperative dental screening (NPDS).
Thus, this prospective registry-based observational before-and-after study aims to investigate the impact of different preoperative dental screening practices on the risk of IE in patients undergoing.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 225 across 82 observational studies indexed under Endocarditis.
Browse Endocarditis studies →Odense University Hospital is the lead sponsor of 479 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients undergoing TAVI from Oktober 2023 to January 2026 from Odense University Hospital and Aalborg University Hospital compared with same type of patients from the same centers from the period January 2020 to June 2023.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No preoperative dental screening in patients undergoing TAVI
Procedure: No preoperative dental screening
Mandatory preoperative dental screening in patients undergoing TAVI
Discontinuance of mandatory preoperative dental screening prior TAVI which also can include oral surgery.
Number of Participants with Infectious Endocarditis
Infectious endocarditis diagnosed by healthcare professionals
Time frame: Through study completion, an average of 1 year
Number of Participants undergoing Oral surgical procedure at dental screening
Number of oral surgical procedure performed in patients as part of the dental screening
Time frame: Through study completion, an average of 1 year
Number of Participants undergoing Tooth extraction at dental screening
Number of Tooth extraction procedure performed in patients as part of the dental screening
Time frame: Through study completion, an average of 1 year
The different Bacteria types causing the infectious endocarditis assessed by blood culture
Reporting all the different bacteria type causing infectious endocarditis, including the rate of each bacteria.
Time frame: Through study completion, an average of 1 year
Number patients with Bacteremia assessed by positive blood culture
Cases of bacteremia in the population.
Time frame: Through study completion, an average of 1 year
Number of Participants with IE caused by bacteria from oral foci
Infectious Endocarditis caused by bacteria from oral foci
Time frame: Through study completion, an average of 1 year
Number of Participants with Cardiac implantable electronic device risk of IE
Cardiac implantable electronic device risk of IE
Time frame: Through study completion, an average of 1 year
Plan to share: Yes — Data from this study, encompassing both individual participant information and a comprehensive data dictionary that defines each field, will be accessible to interested parties. Specifically, we'll be sharing deidentified participant data paired with the mentioned data dictionary. Study protocol and statistical analysis plan will be provided. Prospective researchers can anticipate data availability concurrent with the publication of our findings. To gain access, reach out to Lytfi.Krasniqi@rsyd.dk. Data will be shared with researchers whose proposed use has received approval. Access will be granted primarily for the replication of the results presented in our study.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: To be announced
Access criteria: A signed data access agreement, compliant with regional legislation and data authority requirements, must be obtained prior to data release.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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