Surgical Valve ReplacementDENSVARNCT06403839
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Surgical Valve Replacement Patients
An observational study of Surgical Valve Replacement and Dental, run by Odense University Hospital at 1 site in Denmark.
Trial summary
In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with surgical valve replacement was changed from mandatory to targeted PDS to from march 2024. The investigators will therefore compare the risk of IE before vs after march 2024. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Valve Replacement, Dental, Endocarditis
- What is being tested?
- No preoperative dental screening
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2020to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing surgical valve replacement from March 2024 to March 2027 from Odense University Hospital compared with same type of patients from the same center from the period January 2020 to March 2024.
Who may be able to join
- Patients undergoing surgical valve replacement
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital, Cardiac Surgery Department
Odense, 5000
Lytfi Krasniqi, MD, 004524638899, Lytfi.Krasniqi@rsyd.dk
About this study
Official title: Impact of Targeted Preoperative Dental Screening on Post-procedural Risk of Infective Endocarditis in Patients Undergoing Surgical Valve Replacement: a Prospective Observational Study
In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with surgical valve replacement was changed from mandatory to targeted PDS to from march 2024.
The investigators will therefore compare the risk of IE before vs after march 2024.
Read the detailed description
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 valve replacement 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.
- Conditions
- Surgical Valve Replacement, Dental, Endocarditis
- Being tested
- No preoperative dental screening
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No preoperative dental screeningProcedure or surgery
Discontinuance of mandatory preoperative dental screening prior surgical valve replacement which also can include oral surgery.
| Study group | Role | What they receive |
|---|---|---|
| No preoperative dental screening | No preoperative dental screening in patients undergoing surgical valve replacement. Receives: Procedure: No preoperative dental screening | |
| Mandatory preoperative dental screening | Mandatory preoperative dental screening in patients undergoing surgical valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Infectious Endocarditis
Infectious endocarditis diagnosed by healthcare professionals
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Number of Participants undergoing Oral surgical procedure at dental screening
Number of oral surgical procedure performed in patients as part of the dental screening
Measured: 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
Measured: 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.
Measured: Through study completion, an average of 1 year
Number patients with Bacteremia assessed by positive blood culture
Cases of bacteremia in the population
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jan 2020
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Surgical Valve ReplacementStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lytfi Krasniqi, MD, Principal investigator, Denmark Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403839
- Sponsor's protocol ID
- PET24SVAR
- Acronym
- DENSVAR
- Status last verified
- Oct 2026
- First submitted
- 3 May 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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, the investigators will share 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.
Publications
Que YA, Moreillon P. Infective endocarditis. Nat Rev Cardiol. 2011 Jun;8(6):322-36. doi: 10.1038/nrcardio.2011.43. Epub 2011 Apr 12.
PubMed 21487430Piper C, Korfer R, Horstkotte D. Prosthetic valve endocarditis. Heart. 2001 May;85(5):590-3. doi: 10.1136/heart.85.5.590. No abstract available.
PubMed 11303018Ostergaard L, Valeur N, Ihlemann N, Smerup MH, Bundgaard H, Gislason G, Torp-Pedersen C, Bruun NE, Kober L, Fosbol EL. Incidence and factors associated with infective endocarditis in patients undergoing left-sided heart valve replacement. Eur Heart J. 2018 Jul 21;39(28):2668-2675. doi: 10.1093/eurheartj/ehy153.
PubMed 29584858Delgado V, Ajmone Marsan N, de Waha S, Bonaros N, Brida M, Burri H, Caselli S, Doenst T, Ederhy S, Erba PA, Foldager D, Fosbol EL, Kovac J, Mestres CA, Miller OI, Miro JM, Pazdernik M, Pizzi MN, Quintana E, Rasmussen TB, Ristic AD, Rodes-Cabau J, Sionis A, Zuhlke LJ, Borger MA; ESC Scientific Document Group. 2023 ESC Guidelines for the management of endocarditis. Eur Heart J. 2023 Oct 14;44(39):3948-4042. doi: 10.1093/eurheartj/ehad193. No abstract available.
PubMed 37622656Mentias A, Girotra S, Desai MY, Horwitz PA, Rossen JD, Saad M, Panaich S, Kapadia S, Sarrazin MV. Incidence, Predictors, and Outcomes of Endocarditis After Transcatheter Aortic Valve Replacement in the United States. JACC Cardiovasc Interv. 2020 Sep 14;13(17):1973-1982. doi: 10.1016/j.jcin.2020.05.012.
PubMed 32912457Butt JH, Ihlemann N, De Backer O, Sondergaard L, Havers-Borgersen E, Gislason GH, Torp-Pedersen C, Kober L, Fosbol EL. Long-Term Risk of Infective Endocarditis After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2019 Apr 9;73(13):1646-1655. doi: 10.1016/j.jacc.2018.12.078.
PubMed 30947917Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;143(5):e72-e227. doi: 10.1161/CIR.0000000000000923. Epub 2020 Dec 17. No abstract available.
PubMed 33332150Buckley AJ, Hensey M, O'Connor S, Maree A. Dental screening prior to transcatheter versus surgical aortic valve replacement: International Survey of Current Practices. Catheter Cardiovasc Interv. 2023 Jul;102(1):176-177. doi: 10.1002/ccd.30675. Epub 2023 May 7. No abstract available.
PubMed 37149755Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
PubMed 34453165Krasniqi L, Schodt Riber LP, Nissen H, Terkelsen CJ, Andersen NH, Freeman P, Povlsen JA, Gerke O, Clavel MA, Dahl JS. Impact of mandatory preoperative dental screening on post-procedural risk of infective endocarditis in patients undergoing transcatheter aortic valve implantation: a nationwide retrospective observational study. Lancet Reg Health Eur. 2023 Nov 22;36:100789. doi: 10.1016/j.lanepe.2023.100789. eCollection 2024 Jan.
PubMed 38188272
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Targeted Preoperative Dental Screening on Post-procedural Risk of Infective Endocarditis in Patients Undergoing Surgical Valve Replacement: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06403839
- Acronym / sponsor ID
- DENSVAR / PET24SVAR
- Conditions
- Surgical Valve Replacement, Dental, Endocarditis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with surgical valve replacement was changed from mandatory to targeted PDS to from march 2024.
The investigators will therefore compare the risk of IE before vs after march 2024.
Detailed description
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 valve replacement 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No preoperative dental screening | – | Procedure: No preoperative dental screeningNo preoperative dental screening in patients undergoing surgical valve replacement. |
| Mandatory preoperative dental screening | – | –Mandatory preoperative dental screening in patients undergoing surgical valve replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing surgical valve replacement from March 2024 to March 2027 from Odense University Hospital compared with same type of patients from the same center from the period January 2020 to March 2024.
Key inclusion criteria (1 listed)
- Patients undergoing surgical valve replacement
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No preoperative dental screeningDiscontinuance of mandatory preoperative dental screening prior surgical valve replacement which also can include oral surgery. | Procedure or surgery | No preoperative dental screening |
Primary outcome
Number of Participants with Infectious Endocarditis
Time frame: Through study completion, an average of 1 year
Infectious endocarditis diagnosed by healthcare professionals
6 secondary outcomes
Number of Participants undergoing Oral surgical procedure at dental screening
Time frame: Through study completion, an average of 1 year
Number of Participants undergoing Tooth extraction at dental screening
Time frame: Through study completion, an average of 1 year
The different Bacteria types causing the infectious endocarditis assessed by blood culture
Time frame: Through study completion, an average of 1 year
Number patients with Bacteremia assessed by positive blood culture
Time frame: Through study completion, an average of 1 year
Number of Participants with IE 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
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 21487430Que YA, Moreillon P. Infective endocarditis. Nat Rev Cardiol. 2011 Jun;8(6):322-36. doi: 10.1038/nrcardio.2011.43. Epub 2011 Apr 12.
- Background: PubMed 11303018Piper C, Korfer R, Horstkotte D. Prosthetic valve endocarditis. Heart. 2001 May;85(5):590-3. doi: 10.1136/heart.85.5.590. No abstract available.
- Background: PubMed 29584858Ostergaard L, Valeur N, Ihlemann N, Smerup MH, Bundgaard H, Gislason G, Torp-Pedersen C, Bruun NE, Kober L, Fosbol EL. Incidence and factors associated with infective endocarditis in patients undergoing left-sided heart valve replacement. Eur Heart J. 2018 Jul 21;39(28):2668-2675. doi: 10.1093/eurheartj/ehy153.
- Background: PubMed 37622656Delgado V, Ajmone Marsan N, de Waha S, Bonaros N, Brida M, Burri H, Caselli S, Doenst T, Ederhy S, Erba PA, Foldager D, Fosbol EL, Kovac J, Mestres CA, Miller OI, Miro JM, Pazdernik M, Pizzi MN, Quintana E, Rasmussen TB, Ristic AD, Rodes-Cabau J, Sionis A, Zuhlke LJ, Borger MA; ESC Scientific Document Group. 2023 ESC Guidelines for the management of endocarditis. Eur Heart J. 2023 Oct 14;44(39):3948-4042. doi: 10.1093/eurheartj/ehad193. No abstract available.
- Background: PubMed 32912457Mentias A, Girotra S, Desai MY, Horwitz PA, Rossen JD, Saad M, Panaich S, Kapadia S, Sarrazin MV. Incidence, Predictors, and Outcomes of Endocarditis After Transcatheter Aortic Valve Replacement in the United States. JACC Cardiovasc Interv. 2020 Sep 14;13(17):1973-1982. doi: 10.1016/j.jcin.2020.05.012.
- Background: PubMed 30947917Butt JH, Ihlemann N, De Backer O, Sondergaard L, Havers-Borgersen E, Gislason GH, Torp-Pedersen C, Kober L, Fosbol EL. Long-Term Risk of Infective Endocarditis After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2019 Apr 9;73(13):1646-1655. doi: 10.1016/j.jacc.2018.12.078.
- Background: PubMed 33332150Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;143(5):e72-e227. doi: 10.1161/CIR.0000000000000923. Epub 2020 Dec 17. No abstract available.
- Background: PubMed 37149755Buckley AJ, Hensey M, O'Connor S, Maree A. Dental screening prior to transcatheter versus surgical aortic valve replacement: International Survey of Current Practices. Catheter Cardiovasc Interv. 2023 Jul;102(1):176-177. doi: 10.1002/ccd.30675. Epub 2023 May 7. No abstract available.
- Background: PubMed 34453165Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
- Background: PubMed 38188272Krasniqi L, Schodt Riber LP, Nissen H, Terkelsen CJ, Andersen NH, Freeman P, Povlsen JA, Gerke O, Clavel MA, Dahl JS. Impact of mandatory preoperative dental screening on post-procedural risk of infective endocarditis in patients undergoing transcatheter aortic valve implantation: a nationwide retrospective observational study. Lancet Reg Health Eur. 2023 Nov 22;36:100789. doi: 10.1016/j.lanepe.2023.100789. eCollection 2024 Jan.
- Individual participant dataSharing planned: 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, the investigators will share 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.
Related trials for Surgical Valve Replacement
Active, not recruiting
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
Aortic Valve Stenosis
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
RecruitingObservational study
TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
Heart Valve Diseases, Heart Diseases
Active, not recruiting
Autus Valve Continued Access Study (CAS)
Congenital Heart Disease
Active, not recruiting
Autus Valve Pivotal Study
Congenital Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lytfi Krasniqi, MD principal investigator
Denmark Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Valve Replacement and Dental, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lytfi Krasniqi, MD (004524638899, Lytfi.Krasniqi@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Infectious Endocarditis (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06403839, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.