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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06054360
Other study ID # PI2023_843_0048
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 17, 2023
Est. completion date November 2025

Study information

Verified date September 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Camille DAUMIN, MD
Phone 03 22 08 77 95
Email daumin.camille@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The incidence of postoperative atrial fibrillation (POAF) after cardiac surgery is around 30%. POAF increases the risk of developing permanent atrial fibrillation and raises the risk of cardiac decompensation, stroke, acute myocardial infarction, and death. While the role of the left atrium (LAF) in the pathophysiology of POAF is now well-established, the part of the right atrium (RA) remains poorly understood. Recent studies suggest a correlation between RA function and POAF. RA function can be assessed by transthoracic echocardiography (TTE) with dedicated software for measuring the RA strain (RAS). RA function is thus divided into three phases: reservoir (RASr), conduit, and contraction. Numerous studies have demonstrated that a significant alteration in RAS predicts POAF in various clinical contexts. Therefore, it is essential to investigate whether alterations in RA function assessed by 2D-STE (RAS) are associated with an increased occurrence of FAPO after cardiac surgery. It is essential to investigate whether alterations in RA function assessed by 2D-STE (RAS) are associated with an increased occurrence of FAPO after cardiac surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 334
Est. completion date November 2025
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patient (>18 years old) - The patient was hospitalized at the Amiens University Hospital for scheduled aortocoronary bypass grafting under cardiopulmonary bypass. - Echocardiographic image quality enabling the measurement of RAS parameters - Patient affiliation to a social security scheme - Patient/proxy information and collection of their non-opposition. Exclusion Criteria: - Patients participating in an interventional study may modify the incidence of POAF. - History of atrial fibrillation or flutter. - Valvular and ascending aorta cardiac surgery - Urgent cardiac surgery. - Presence of tricuspid insufficiency greater than grade 2. - Left ventricular ejection fraction lower than 50%. - Patient receiving circulatory mechanical assistance before surgery. - Dependency on ventricular and atrial pacing by an internal or external cardiac pacemaker during the echocardiographic examination.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Amiens Picardie Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of RASr parameter variation with POAF incidence Correlation of RASr parameter variation with POAF incidence in patients undergoing postoperative cardiac surgery 30 months
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