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

NCT07266935 | Completed

• 1 other identifier: TaizU-PP-AF-2022
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Atrial Fibrillation; Cardiac Tamponade

Keywords

Posterior pericardiotomy; Postoperative atrial fibrillation; Cardiac tamponade; Yemen

Outcome Measures

Primary Outcomes (1)

• 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.

  During hospitalization, approximately 5-7 days

Secondary Outcomes (9)

• Number of participants requiring postoperative antiarrhythmic medications

  From surgery until hospital discharge (average 7-10 days)

• Number of Participants Requiring Systemic Anticoagulation or Cardioversion for Arrhythmia

  From surgery until hospital discharge (average 7-10 days)

• Number of participants with cardiac tamponade requiring intervention

  From date of surgery through 30 days postoperatively

• Number of participants requiring surgical re-exploration for bleeding or tamponade

  From date of surgery through 30 days postoperatively

• Duration of Mechanical Ventilation (Hours)

  From end of surgery until successful extubation (up to 72 hours postoperatively)

Study Arms (2)

Interventional: Posterior Pericardiotomy

EXPERIMENTAL

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

Control: Standard Care

ACTIVE COMPARATOR

Conventional open-heart surgery is performed without posterior pericardiotomy. Standard perioperative care is provided.

Procedure: Standard Care

Interventions

Posterior Pericardiotomy PROCEDURE

A longitudinal posterior pericardiotomy incision (4-5 cm) is made parallel and posterior to the left phrenic nerve during open-heart surgery.

Interventional: Posterior Pericardiotomy

Standard Care PROCEDURE

Conventional open-heart surgery without posterior pericardiotomy. Standard perioperative care is provided.

Control: Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Elective open-heart surgery:
• Coronary artery bypass grafting (CABG) Aortic valve replacement Ascending aortic surgery Combined procedures (e.g., CABG + valve replacement)

You may not qualify if:

• Previous cardiac or thoracic surgery
• Left-sided pleural adhesions
• Preoperative atrial fibrillation or other rhythm disorders
• Hyperthyroidism
• Renal failure with plasma creatinine \>2.0 mg/dL
• Off-pump CABG
• Mitral or tricuspid valve surgery (excluded due to distinct pathophysiology and POAF risk)
• Refusal to participate

Sponsors & Collaborators

• Taiz University - Faculty of Medicine: lead

Study Sites (1)

Cardiovascular & Kidney Transplantation Centre, Taiz University, Taiz, Yemen

Taiz, Muḩāfaz̧at Ta‘izz, Yemen

Location

Related Publications (1)

• Al-Shameri I, Al-Ganadi AA, Noman T, Kadry MA, Elsharkawy IM, Al-Wsabi N, Mohammed AA. Posterior Pericardiotomy and Its Impact on Cardiac Tamponade and Pericardial Effusion after Cardiac Surgery. Ann Thorac Cardiovasc Surg. 2025;31(1):25-00075. doi: 10.5761/atcs.oa.25-00075.

  PMID: 40603058 BACKGROUND

MeSH Terms

Conditions

Cardiac Tamponade

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ismail S Al Shameri, MD

  Cardiovascular & Kidney Transplantation Centre, Taiz University, Yemen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to the treatment group; participants and care providers were aware of the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: December 5, 2025
• Study Start: January 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: December 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

YE (1)