An interventional study of Posterior Pericardiotomy and Standard Care in Postoperative Atrial Fibrillation and Cardiac Tamponade, sponsored by Taiz University - Faculty of Medicine. Completed at 1 site in Yemen. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Taiz University - Faculty of Medicine · Not applicable, Interventional, and Prevention
A single-center, randomized controlled trial in Yemen evaluating whether posterior pericardiotomy (PP) reduces postoperative atrial fibrillation (POAF) after open-heart surgery. 210 patients undergoing CABG, aortic valve replacement, ascending aortic surgery, or combined procedures were randomized 1:1 to receive either posterior pericardiotomy (PP group, n = 106) or standard care (control group, n = 104). Outcomes assessed included POAF incidence, pericardial effusion, cardiac tamponade, ICU stay, mechanical ventilation, in-hospital mortality, and re-exploration for bleeding or tamponade.
This single-center, prospective randomized controlled trial was conducted at the Cardiovascular and Kidney Transplantation Centre, Taiz University, Yemen. Adult patients undergoing elective open-heart surgery were randomized to receive either posterior pericardiotomy or standard care. The intervention involved creating a longitudinal posterior pericardiotomy incision parallel to the left phrenic nerve to facilitate pericardial drainage into the left pleural cavity.
The study evaluated the impact of posterior pericardiotomy on postoperative atrial fibrillation and related complications, including pericardial effusion and cardiac tamponade, compared with standard surgical management. Participants were monitored during hospitalization and followed for 30 days after surgery to assess clinical outcomes, resource utilization, and mortality.
This is the only study on the registry with Taiz University - Faculty of Medicine as lead sponsor.
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Coronary artery bypass grafting (CABG) Aortic valve replacement Ascending aortic surgery Combined procedures (e.g., CABG + valve replacement)
Exclusion Criteria:
A longitudinal posterior pericardiotomy incision (4-5 cm) is made parallel and posterior to the left phrenic nerve during open-heart surgery. This intervention aims to reduce postoperative atrial fibrillation, pericardial effusion, and cardiac tamponade.
Procedure: Posterior Pericardiotomy
Conventional open-heart surgery is performed without posterior pericardiotomy. Standard perioperative care is provided.
Procedure: Standard Care
A longitudinal posterior pericardiotomy incision (4-5 cm) is made parallel and posterior to the left phrenic nerve during open-heart surgery.
Conventional open-heart surgery without posterior pericardiotomy. Standard perioperative care is provided.
Number of participants with postoperative atrial fibrillation (POAF) until hospital discharge
Occurrence of atrial fibrillation documented by 12-lead ECG or continuous telemetry monitoring, lasting \>30 seconds, and occurring after cardiac surgery in patients with no prior history of atrial fibrillation.
Time frame: During hospitalization, approximately 5-7 days
Number of participants requiring postoperative antiarrhythmic medications
Any antiarrhythmic therapy administered postoperatively to manage POAF
Time frame: From surgery until hospital discharge (average 7-10 days)
Number of Participants Requiring Systemic Anticoagulation or Cardioversion for Arrhythmia
Any anticoagulation therapy or cardioversion performed for arrhythmia management
Time frame: From surgery until hospital discharge (average 7-10 days)
Number of participants with cardiac tamponade requiring intervention
Clinically diagnosed cardiac tamponade requiring intervention
Time frame: From date of surgery through 30 days postoperatively
Number of participants requiring surgical re-exploration for bleeding or tamponade
Any return to surgery for bleeding or tamponade relief
Time frame: From date of surgery through 30 days postoperatively
Duration of Mechanical Ventilation (Hours)
Total hours under mechanical ventilation until successful extubation
Time frame: From end of surgery until successful extubation (up to 72 hours postoperatively)
Duration of ICU stay (hours)
Total time in ICU from admission to transfer to ward
Time frame: From ICU admission after surgery until transfer to ward (average of 1-4 days)
Duration of total hospital stay (days)
Days from surgery to discharge
Time frame: From date of surgery until hospital discharge (average of 7-10 days)
Number of participants with in-hospital mortality (any cause)
Death from any cause during hospital stay
Time frame: From date of surgery until hospital discharge (average of 7-10 days)
Number of participants experiencing major adverse cardiovascular events (MACE: stroke, myocardial infarction, or death)
Occurrence of stroke, myocardial infarction, or all-cause mortality
Time frame: From date of surgery through 30 days postoperatively
Plan to share: No
Ran from Jan 2022 to primary completion in Jun 2024, 29 months.
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Cardiac Tamponade