Cardiac SurgeryPFASNCT07625033
Risk Factors of Atrial Fibrillation After Cardiac Surgery
An observational study of Cardiac Surgery and Peri Operative Medicine, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
Supraventricular arrhythmias complicate more than 40% of cardiac surgeries and are associated with an increased risk of bleeding, stroke, heart failure, and death. Preventing the occurrence of these arrhythmias is a major challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Peri Operative Medicine, Thoracic Surgery
- How many people
- 918 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2026to 1 Jul 2026
- Phase
- Observational
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: Patients having undergone a scheduled cardiac surgery in the study center and having agreed to the reuse of their hospital care data
Who may be able to join
- age >18
- having undergone a scheduled cardiac surgery in the study center
- having agreed to the reuse of their hospital care data
Who cannot join
- Atrial fibrillation at the admission in hospital.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Supraventricular arrhythmias complicate more than 40% of cardiac surgeries and are associated with an increased risk of bleeding, stroke, heart failure, and death. Preventing the occurrence of these arrhythmias is a major challenge. This study aims to investigate risk factors and protective factors regarding atrial fibrillation and other iatrogenic cardiac arrhythmias after cardiac surgery, particularly innovative anesthetic strategies such as stellar ganglion blockade which have been recently implemented in our center.
Read the detailed description
STUDY OBJECTIVE
The aim of this study is to compare atrial fibrillation incidence between patients having undergone a cardiac surgery with a stellate ganglion block and patients having undergone a cardiac surgery without a stellate ganglion block .
STUDY PROCEDURES
This study does not require any additional examinations or specific treatments. It uses information already routinely available in the CHR Mercy electronic medical record systems (Diane, Metavision, dxCare).
This is a prospective single-center study. Patients referred for cardiac surgery (both off-pump and on-pump procedures) will be included for data collection between June 2026 and June 2029. The use of a stellate ganglion block after a cardiac surgery is a routine practice in our hospital that varies depending on the intensivist and/or the time period.
Clinical, demographic, and biological data will be collected in patient records. Perioperative data related to the surgical procedure will also be collected, as well as data regarding the management and clinical course during the intensive care unit stay.
The socio-demographic data collected as part of routine clinical care will include: age, sex, past medical and surgical history, chronic medications, type of cardiac disease, coronary angiography findings, history of coronary stenting, stent localization, preoperative assessment (lower limb Doppler ultrasound, carotid Doppler ultrasound), type of coronary artery bypass surgery (off-pump/on-pump), and history of cardiac arrhythmias.
The following clinical data, routinely collected on a daily basis as part of standard care, will be recorded: blood pressure, heart rate, body temperature, respiratory rate, duration of mechanical ventilation, daily urine output (mL), FiO2 (for intubated patients, otherwise oxygen flow rate), need for non-invasive ventilation (Yes/No) assessed daily, mobilization to chair (Yes/No), presence of clinical Claude Bernard-Horner syndrome, recurrent laryngeal nerve palsy, swallowing disorders/aspiration events, inflammatory signs around the perineural catheter, pain at the puncture site/cervical region, chest pain assessed using a visual analogue scale (VAS), signs of phrenic nerve paralysis (reduced thoracic expansion on the stellate block side), acute neurological disorders (confusion, agitation, seizures), daily chest drain output, number and location of chest drains, type and dosage of inotropic support (dobutamine, levosimendan), type and dosage of vasopressors (norepinephrine, vasopressin).
The following paraclinical data will be monitored daily: ECG recordings (D1, D2, D3, D4), continuous ECG Holter monitoring, chest X-ray on D0 as part of routine care, and transthoracic echocardiography (TTE) performed routinely on D1, D2, D3, and D4, including: left ventricular outflow tract velocity-time integral (LVOT VTI), heart rate, LVOT area (cardiac output/cardiac index calculation), E-wave velocity (cm/s), A-wave velocity (cm/s), mitral E' velocity (cm/s), TAPSE (mm), tricuspid S-wave velocity (cm/s), pericardial effusion (Yes/No), inferior vena cava diameter (mm), aortic regurgitation grade (1-4), mitral regurgitation grade (1-4), maximum intraventricular gradient (mmHg), and mean transvalvular gradient (mmHg).
Biological data collected as part of routine care
Day 0 (D0)
Serum electrolytes (sodium, potassium), renal function tests (serum creatinine, urea), liver function tests (AST, ALT, gamma-GT, alkaline phosphatase, total bilirubin, conjugated bilirubin), troponin, NT-proBNP, CPK, complete blood count, PT, aPTT, fibrinogen, and serum bicarbonate levels.
Day 1 (D1) (and all consecutive days in ICU)
Serum electrolytes (sodium, potassium), renal function tests (serum creatinine, urea), liver function tests (AST, ALT, gamma-GT, alkaline phosphatase, total bilirubin, conjugated bilirubin), troponin, NT-proBNP, CPK, complete blood count, PT, aPTT, fibrinogen, serum bicarbonates, plus venous blood gas analysis (pH, lactate, PaO2, PaCO2, bicarbonates, ScvO2) and arterial blood gas analysis (pH, lactate, PaO2, PaCO2, bicarbonates, SaO2, PaO2/FiO2 ratio).
Those biological data will be monitored as long as the patient is in ICU.
- Conditions
- Cardiac Surgery, Peri Operative Medicine, Thoracic Surgery, Cardiopulmonary Bypass, Coronary Artery Bypass, Heart Valve Prosthesis Implantation
- Keywords
- Stellar Ganglion Blockade, SGB, cardiac surgery
- Medical subject headings
- Simpson-Golabi-Behmel syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of postoperative atrial fibrillation
monitor on cardiac ECG monitoring performed during the routine cares in cardiac ICU
Measured: from cardiac surgery (day 0) up to ICU discharge (about 3 days on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- 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
- 918 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625033
- Sponsor's protocol ID
- 2026-03-Obs-CHRMT
- Acronym
- PFAS
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No