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

NCT07266935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2025-12-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Taiz University - Faculty of Medicine

    lead OTHER

Principal Investigators

  • Ismail S Al Shameri, MD · Cardiovascular & Kidney Transplantation Centre, Taiz University, Yemen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Yemen

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07266935 on ClinicalTrials.gov