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Completed

NCT Number: NCT07266935

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

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.

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Key information

Conditions

Postoperative Atrial Fibrillation Cardiac Tamponade Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Taiz, Muḩāfaz̧at Ta‘izz, Yemen

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

Standard care

Procedure

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

Primary outcomes

  1. Number of participants with postoperative atrial fibrillation (POAF) until hospital discharge

    Time frame: During hospitalization, approximately 5-7 days

    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.

Secondary outcomes

  1. Number of participants requiring postoperative antiarrhythmic medications

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

    Any antiarrhythmic therapy administered postoperatively to manage POAF

  2. Number of Participants Requiring Systemic Anticoagulation or Cardioversion for Arrhythmia

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

    Any anticoagulation therapy or cardioversion performed for arrhythmia management

  3. Number of participants with cardiac tamponade requiring intervention

    Time frame: From date of surgery through 30 days postoperatively

    Clinically diagnosed cardiac tamponade requiring intervention

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

    Time frame: From date of surgery through 30 days postoperatively

    Any return to surgery for bleeding or tamponade relief

  5. Duration of Mechanical Ventilation (Hours)

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

    Total hours under mechanical ventilation until successful extubation

  6. Duration of ICU stay (hours)

    Time frame: From ICU admission after surgery until transfer to ward (average of 1-4 days)

    Total time in ICU from admission to transfer to ward

  7. Duration of total hospital stay (days)

    Time frame: From date of surgery until hospital discharge (average of 7-10 days)

    Days from surgery to discharge

  8. Number of participants with in-hospital mortality (any cause)

    Time frame: From date of surgery until hospital discharge (average of 7-10 days)

    Death from any cause during hospital stay

  9. Number of participants experiencing major adverse cardiovascular events (MACE: stroke, myocardial infarction, or death)

    Time frame: From date of surgery through 30 days postoperatively

    Occurrence of stroke, myocardial infarction, or all-cause mortality

Sponsors and collaborators

Lead sponsor

Taiz University - Faculty of Medicine

Other

Registry information

Official study title

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

Acronym: PP-POAF

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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