Valve Heart DiseasePOMI-AFNCT03376165
Post-Operative Myocardial Incident & Atrial Fibrillation
An observational study of Valve Heart Disease and Coronary Artery Disease, run by University Hospital, Lille at 1 site in France.
Trial summary
To explore predictors of major cardio-vascular events after cardiac surgery and trans-catheter valve implantation with a specific interest in studying mechanisms linking pre-operative leukocyte, fat and myocardial phenotypes with post-intervention outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valve Heart Disease, Coronary Artery Disease
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2018to Jan 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 adult patients schedulled for cardiac surgery (coronary artery bypass graft surgery and/or valvular surgery) or transcatheter valve implantation and referred to the University Hospital of Lille with inclusion criteria and no exclusion criteria.
Who may be able to join
- patients scheduled for cardiac surgery (coronary artery bypass graft surgery and/or valvular surgery) or transcatheter valve implantation
Who cannot join
- pregnant woman
- urgent surgery or intervention
- not able to consent to the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Cardiologie, CHU
Lille
David Montaigne, MD,PhD
About this study
Official title: Longitudinal Study of Patients Undergoing Cardiac Surgery or Implantation of a Percutaneous Valve Prosthesis
To explore predictors of major cardio-vascular events after cardiac surgery and trans-catheter valve implantation with a specific interest in studying mechanisms linking pre-operative leukocyte, fat and myocardial phenotypes with post-intervention outcomes.
- Conditions
- Valve Heart Disease, Coronary Artery Disease
- Keywords
- prognosis, translational research
- Medical subject headings
- Heart Valve Diseases, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation)
cardiovascular death, hospitalisation for heart failure, stroke, myocardial infarction, re-intervention
Measured: from the day of intervention to 10 years
Secondary outcomes (4)
peri-operative myocardial injury
Area Under the Curve of blood troponin release during the 3 days following cardiac intervention
Measured: 3 days following intervention
post-operative myocardial infarction (type 5 myocardial infarction)
myocardial infarction during the peri-operative time
Measured: 10 days following intervention
post-operative atrial fibrillation
atrial fibrillation onset during post-op hospitalisation
Measured: 10 days following intervention
major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation)
cardiovascular death, hospitalisation for heart failure, stroke, myocardial infarction, re-intervention
Measured: from the day of intervention to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start30 Jan 2018
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Valve Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Montaigne, Prof., Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376165
- Sponsor's protocol ID
- CB2015_75
- Other IDs
- 2017-A00852-51
- Acronym
- POMI-AF
- Status last verified
- May 2026
- First submitted
- 11 Dec 2017
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ninni S, Dombrowicz D, Kuznetsova T, Vicario R, Gao V, Molendi-Coste O, Haas J, Woitrain E, Coisne A, Neele AE, Prange K, Willemsen L, Aghezzaf S, Fragkogianni S, Tazibet A, Pineau L, White JR, Eeckhoute J, Koussa M, Dubrulle H, Juthier F, Soquet J, Vincentelli A, Edme JL, de Winther M, Geissmann F, Staels B, Montaigne D. Hematopoietic Somatic Mosaicism Is Associated With an Increased Risk of Postoperative Atrial Fibrillation. J Am Coll Cardiol. 2023 Apr 4;81(13):1263-1278. doi: 10.1016/j.jacc.2023.01.036.
PubMed 36990546Ninni S, Vicario R, Coisne A, Woitrain E, Tazibet A, Stewart CM, Diaz LA Jr, White JR, Koussa M, Dubrulle H, Juthier F, Jungling M, Vincentelli A, Edme JL, Nattel S, de Winther M, Geissmann F, Dombrowicz D, Staels B, Montaigne D. Clonal Hematopoiesis Is Associated With Long-Term Adverse Outcomes Following Cardiac Surgery. J Am Heart Assoc. 2024 Sep 3;13(17):e034255. doi: 10.1161/JAHA.123.034255. Epub 2024 Aug 29.
PubMed 39206728
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Patients Undergoing Cardiac Surgery or Implantation of a Percutaneous Valve Prosthesis
- ClinicalTrials.gov ID
- NCT03376165
- Acronym / sponsor ID
- POMI-AF / CB2015_75
- Conditions
- Valve Heart Disease, Coronary Artery Disease
- Keywords
- prognosis, translational research
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 18 Dec 2017 (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.
To explore predictors of major cardio-vascular events after cardiac surgery and trans-catheter valve implantation with a specific interest in studying mechanisms linking pre-operative leukocyte, fat and myocardial phenotypes with post-intervention outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients schedulled for cardiac surgery (coronary artery bypass graft surgery and/or valvular surgery) or transcatheter valve implantation and referred to the University Hospital of Lille with inclusion criteria and no exclusion criteria.
Key inclusion criteria (1 listed)
- patients scheduled for cardiac surgery (coronary artery bypass graft surgery and/or valvular surgery) or transcatheter valve implantation
Key exclusion criteria (3 listed)
- pregnant woman
- urgent surgery or intervention
- not able to consent to the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation)
Time frame: from the day of intervention to 10 years
cardiovascular death, hospitalisation for heart failure, stroke, myocardial infarction, re-intervention
4 secondary outcomes
peri-operative myocardial injury
Time frame: 3 days following intervention
post-operative myocardial infarction (type 5 myocardial infarction)
Time frame: 10 days following intervention
post-operative atrial fibrillation
Time frame: 10 days following intervention
major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation)
Time frame: from the day of intervention to 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 14 May 2026.
- Results publication: PubMed 36990546Ninni S, Dombrowicz D, Kuznetsova T, Vicario R, Gao V, Molendi-Coste O, Haas J, Woitrain E, Coisne A, Neele AE, Prange K, Willemsen L, Aghezzaf S, Fragkogianni S, Tazibet A, Pineau L, White JR, Eeckhoute J, Koussa M, Dubrulle H, Juthier F, Soquet J, Vincentelli A, Edme JL, de Winther M, Geissmann F, Staels B, Montaigne D. Hematopoietic Somatic Mosaicism Is Associated With an Increased Risk of Postoperative Atrial Fibrillation. J Am Coll Cardiol. 2023 Apr 4;81(13):1263-1278. doi: 10.1016/j.jacc.2023.01.036.
- Derived from this study: PubMed 39206728Ninni S, Vicario R, Coisne A, Woitrain E, Tazibet A, Stewart CM, Diaz LA Jr, White JR, Koussa M, Dubrulle H, Juthier F, Jungling M, Vincentelli A, Edme JL, Nattel S, de Winther M, Geissmann F, Dombrowicz D, Staels B, Montaigne D. Clonal Hematopoiesis Is Associated With Long-Term Adverse Outcomes Following Cardiac Surgery. J Am Heart Assoc. 2024 Sep 3;13(17):e034255. doi: 10.1161/JAHA.123.034255. Epub 2024 Aug 29.
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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.
David Montaigne, Prof. principal investigator
University Hospital, Lille
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 Valve Heart Disease and Coronary Artery Disease, run by University Hospital, Lille at 1 site in France.
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 3 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 14 May 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 France. 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 David Montaigne, Prof. (320445230 ext. +33, david.montaigne@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation) (time frame: from the day of intervention to 10 years). 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 NCT03376165, which also lists 2 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 14 May 2026.