Postoperative Atrial FibrillationPP-POAFNCT07266935
Posterior Pericardiotomy for Prevention of POAF After Cardiac Surgery: RCT in Yemen
A study testing Posterior Pericardiotomy in people with Postoperative Atrial Fibrillation and Cardiac Tamponade, run by Taiz University - Faculty of Medicine at 1 site in Yemen.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Atrial Fibrillation, Cardiac Tamponade
- What is being tested?
- Posterior Pericardiotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteYemen
- Study dates
- 1 Jan 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Yemen1 site
Cardiovascular & Kidney Transplantation Centre, Taiz University, Taiz, Yemen
Taiz, Muḩāfaz̧at Ta‘izz
About this study
Official title: A Prospective, Randomized Controlled Trial Evaluating the Effectiveness of Posterior Pericardiotomy in Preventing Postoperative Atrial Fibrillation Among Yemeni Cardiac Surgical Patients
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.
Read the 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.
- Being tested
- Posterior Pericardiotomy, Standard Care
- Keywords
- Posterior pericardiotomy, Postoperative atrial fibrillation, Cardiac tamponade, Yemen
- Medical subject headings
- Cardiac Tamponade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior PericardiotomyProcedure or surgery
A longitudinal posterior pericardiotomy incision (4-5 cm) is made parallel and posterior to the left phrenic nerve during open-heart surgery.
Standard CareProcedure or surgery
Conventional open-heart surgery without posterior pericardiotomy. Standard perioperative care is provided.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Posterior Pericardiotomy |
| Control: Standard Care | Active comparator | Conventional open-heart surgery is performed without posterior pericardiotomy. Standard perioperative care is provided. Receives: Procedure: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During hospitalization, approximately 5-7 days
Secondary outcomes (9)
Number of participants requiring postoperative antiarrhythmic medications
Any antiarrhythmic therapy administered postoperatively to manage POAF
Measured: 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
Measured: From surgery until hospital discharge (average 7-10 days)
Number of participants with cardiac tamponade requiring intervention
Clinically diagnosed cardiac tamponade requiring intervention
Measured: 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
Measured: From date of surgery through 30 days postoperatively
Duration of Mechanical Ventilation (Hours)
Total hours under mechanical ventilation until successful extubation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From date of surgery through 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Jan 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiz University - Faculty of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ismail S Al Shameri, MD, Principal investigator, Cardiovascular & Kidney Transplantation Centre, Taiz University, Yemen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266935
- Sponsor's protocol ID
- TaizU-PP-AF-2022
- Acronym
- PP-POAF
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40603058
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Trial Evaluating the Effectiveness of Posterior Pericardiotomy in Preventing Postoperative Atrial Fibrillation Among Yemeni Cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT07266935
- Acronym / sponsor ID
- PP-POAF / TaizU-PP-AF-2022
- Keywords
- Posterior pericardiotomy, Postoperative atrial fibrillation, Cardiac tamponade, Yemen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Taiz University - Faculty of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional: Posterior Pericardiotomy | Experimental | Procedure: Posterior PericardiotomyA 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. |
| Control: Standard Care | Active comparator | Procedure: Standard CareConventional open-heart surgery is performed without posterior pericardiotomy. Standard perioperative care is provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior PericardiotomyA longitudinal posterior pericardiotomy incision (4-5 cm) is made parallel and posterior to the left phrenic nerve during open-heart surgery. | Procedure or surgery | Interventional: Posterior Pericardiotomy |
| Standard CareConventional open-heart surgery without posterior pericardiotomy. Standard perioperative care is provided. | Procedure or surgery | Control: Standard Care |
Primary outcome
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.
9 secondary outcomes
Number of participants requiring postoperative antiarrhythmic medications
Time frame: From surgery until hospital discharge (average 7-10 days)
Number of Participants Requiring Systemic Anticoagulation or Cardioversion for Arrhythmia
Time frame: From surgery until hospital discharge (average 7-10 days)
Number of participants with 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
Time frame: From date of surgery through 30 days postoperatively
Duration of Mechanical Ventilation (Hours)
Time frame: From end of surgery until successful extubation (up to 72 hours postoperatively)
Duration of ICU stay (hours)
Time frame: From ICU admission after surgery until transfer to ward (average of 1-4 days)
Duration of total hospital stay (days)
Time frame: From date of surgery until hospital discharge (average of 7-10 days)
Number of participants with in-hospital mortality (any cause)
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)
Time frame: From date of surgery through 30 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 40603058Al-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail S Al Shameri, MD principal investigator
Cardiovascular & Kidney Transplantation Centre, Taiz University, Yemen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior Pericardiotomy in people with Postoperative Atrial Fibrillation and Cardiac Tamponade, run by Taiz University - Faculty of Medicine at 1 site in Yemen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Yemen. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with postoperative atrial fibrillation (POAF) until hospital discharge (time frame: During hospitalization, approximately 5-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07266935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.