NCT07266935

Posterior Pericardiotomy for Prevention of POAF After Cardiac Surgery: RCT in Yemen

A Prospective, Randomized Controlled Trial Evaluating the Effectiveness of Posterior Pericardiotomy in Preventing Postoperative Atrial Fibrillation Among Yemeni Cardiac Surgical Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Taiz University - Faculty of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Postoperative Atrial Fibrillation
• Cardiac Tamponade

Interventions

Type	Name	Description
PROCEDURE	Posterior Pericardiotomy	A longitudinal posterior pericardiotomy incision (4-5 cm) is made parallel and posterior to the left phrenic nerve during open-heart surgery.
PROCEDURE	Standard Care	Conventional open-heart surgery without posterior pericardiotomy. Standard perioperative care is provided.

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: Yemen