Trial · NCT07887022
Randomized Interventional Clinical Trial on the Prevention of Atrial Fibrillation Using Colchicine, Amiodarone And a Posterior Pericardiotomy.
NCT07887022, Phase 3, Not yet recruiting, Elsan
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Interventional Clinical Trial on the Prevention of Atrial Fibrillation Using Colchicine, Amiodarone And a Posterior Pericardiotomy. Trials, record NCT07887022. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07887022
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Interventional Clinical Trial on the Prevention of Atrial Fibrillation Using Colchicine, Amiodarone And a Posterior Pericardiotomy.
- NCT number
- NCT07887022
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 636 participants, estimated
- Lead sponsor
- Elsan
- Conditions
- Atrial Fibrillation (AF)
- Interventions
- Colchicine, Amiodarone, Posterior pericardiotomy
- First posted
- 2026-10-21
- Last updated
- 2026-10-21
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in the number of patients presenting an episode of persistent AF between control group and the two experimental groups | From enrollment to seven days after the surgery | The primary endpoint is the difference in the number of patients presenting an episode of persistent AF (defined as an AF episode lasting more than 30 minutes as documented by scopic and telemetric monitoring) during their hospitalisation. AF is defined by the ESC as RR interval irregularity, absence of repeated P waves, and irregular atrial activations. The SoC group will be compared to the other two groups of the study. Any episode of persistent AF will be recorded by the usual telemetric monitoring used in post-cardiac surgery monitoring and confirmed by a specialist's review of the trace. |
| Secondary | Difference in the number of patients presenting an episode of persistent AF between the two experimental groups | From enrollment to seven days after the surgery | Difference in the number of patients presenting an episode of persistent AF during the postoperative follow-up hospitalization after cardiac surgery, of the preventive treatment bundle (associating colchicine, amiodarone, and posterior pericardial window) compared to the posterior pericardial window alone. |
| Secondary | Impact on the duration of hospitalisation | From enrollment until end of hospitalisation (maximum of 3 years) | Duration of hospitalisation in days. Comparison of the preventive treatment bundle with the standard of care. Comparison of the posterior pericardial window alone compared to the standard of care. Comparison of the preventive treatment bundle compared to the posterior pericardial window alone. |
| Secondary | Incidence of pericardial effusion requiring surgical correction during the hospitalization | From enrollment until end of hospitalisation (maximum of 3 years) | Efficacy to decrease the incidence of pericardial effusion (requiring surgical correction) during hospitalization: * Comparison of the preventive treatment bundle with the standard of care. * Comparison of the posterior pericardial window alone compared to the standard of care. * Comparison of the preventive treatment bundle compared to the posterior pericardial window alone. |
| Secondary | Incidence of the introduction of anticoagulants during hospitalization | From enrollment until end of hospitalisation (maximum of 3 years) | Efficacy to decrease the number of patients for whom treatment with anticoagulants is necessary during hospitalization (in the case of a POAF episode of 48h or more or in case of POAF recurrence): * Comparison of the preventive treatment bundle with the standard of care. * Comparison of the posterior pericardial window alone compared to the standard of care. * Comparison of the preventive treatment bundle compared to the posterior pericardial window alone |
| Secondary | Incidence of cardiac conduction disorders requiring temporary electro-training during hospitalization | From enrollment until end of hospitalisation (maximum of 3 years) | Efficacy to reduce the occurrence of cardiac conduction disorders during hospitalization: * Comparison of the preventive treatment bundle with the standard of care. * Comparison of the posterior pericardial window alone compared to the standard of care. * Comparison of the preventive treatment bundle compared to the posterior pericardial window alone. |
| Secondary | Cardiac health of patients at 1 year | At 1 year post-surgery | General health state of patients as well as electrocardiogram and current treatments for cardiac disorders (based on data from standard follow-up by the patient's cardiologist) * Comparison of the preventive treatment bundle with the standard of care. * Comparison of the posterior pericardial window alone compared to the standard of care. * Comparison of the preventive treatment bundle compared to the posterior pericardial window alone |
| Secondary | Cardiac health of patients at 3 years | At 3 years post-surgery | General health state of patients as well as electrocardiogram and current treatments for cardiac disorders (based on data from standard follow-up by the patient's cardiologist) * Comparison of the preventive treatment bundle with the standard of care. * Comparison of the posterior pericardial window alone compared to the standard of care. * Comparison of the preventive treatment bundle compared to the posterior pericardial window alone |
| Other | Incidence of gastrointestinal disorders | From enrollment to the end of follow-up (maximum of 3 years) | |
| Other | Number of adverse reactions | From enrollment to the end of follow-up (maximum of 3 years) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07887022
GET https://conductscience.org/api/trials/v1/NCT07887022/registered