Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
Study NCT ID:
NCT07266935
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2025-09-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Posterior Pericardiotomy for Prevention of POAF After Cardiac Surgery: RCT in Yemen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002305', 'term': 'Cardiac Tamponade'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors were blinded to the treatment group; participants and care providers were aware of the intervention.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-09-26', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with postoperative atrial fibrillation (POAF) until hospital discharge', 'timeFrame': 'During hospitalization, approximately 5-7 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of participants requiring postoperative antiarrhythmic medications', 'timeFrame': 'From surgery until hospital discharge (average 7-10 days)', 'description': 'Any antiarrhythmic therapy administered postoperatively to manage POAF'}, {'measure': 'Number of Participants Requiring Systemic Anticoagulation or Cardioversion for Arrhythmia', 'timeFrame': 'From surgery until hospital discharge (average 7-10 days)', 'description': 'Any anticoagulation therapy or cardioversion performed for arrhythmia management'}, {'measure': 'Number of participants with cardiac tamponade requiring intervention', 'timeFrame': 'From date of surgery through 30 days postoperatively', 'description': 'Clinically diagnosed cardiac tamponade requiring intervention'}, {'measure': 'Number of participants requiring surgical re-exploration for bleeding or tamponade', 'timeFrame': 'From date of surgery through 30 days postoperatively', 'description': 'Any return to surgery for bleeding or tamponade relief'}, {'measure': 'Duration of Mechanical Ventilation (Hours)', 'timeFrame': 'From end of surgery until successful extubation (up to 72 hours postoperatively)', 'description': 'Total hours under mechanical ventilation until successful extubation'}, {'measure': 'Duration of ICU stay (hours)', 'timeFrame': 'From ICU admission after surgery until transfer to ward (average of 1-4 days)', 'description': 'Total time in ICU from admission to transfer to ward'}, {'measure': 'Duration of total hospital stay (days)', 'timeFrame': 'From date of surgery until hospital discharge (average of 7-10 days)', 'description': 'Days from surgery to discharge'}, {'measure': 'Number of participants with in-hospital mortality (any cause)', 'timeFrame': 'From date of surgery until hospital discharge (average of 7-10 days)', 'description': 'Death from any cause during hospital stay'}, {'measure': 'Number of participants experiencing major adverse cardiovascular events (MACE: stroke, myocardial infarction, or death)', 'timeFrame': 'From date of surgery through 30 days postoperatively', 'description': 'Occurrence of stroke, myocardial infarction, or all-cause mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Posterior pericardiotomy', 'Postoperative atrial fibrillation', 'Cardiac tamponade', 'Yemen'], 'conditions': ['Postoperative Atrial Fibrillation', 'Cardiac Tamponade']}, 'referencesModule': {'references': [{'pmid': '40603058', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* Elective open-heart surgery:\n\nCoronary artery bypass grafting (CABG) Aortic valve replacement Ascending aortic surgery Combined procedures (e.g., CABG + valve replacement)\n\nExclusion Criteria:\n\n* Previous cardiac or thoracic surgery\n* Left-sided pleural adhesions\n* Preoperative atrial fibrillation or other rhythm disorders\n* Hyperthyroidism\n* Renal failure with plasma creatinine \\>2.0 mg/dL\n* Off-pump CABG\n* Mitral or tricuspid valve surgery (excluded due to distinct pathophysiology and POAF risk)\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT07266935', 'acronym': 'PP-POAF', 'briefTitle': 'Posterior Pericardiotomy for Prevention of POAF After Cardiac Surgery: RCT in Yemen', 'organization': {'class': 'OTHER', 'fullName': 'Taiz University - Faculty of Medicine'}, 'officialTitle': 'A Prospective, Randomized Controlled Trial Evaluating the Effectiveness of Posterior Pericardiotomy in Preventing Postoperative Atrial Fibrillation Among Yemeni Cardiac Surgical Patients', 'orgStudyIdInfo': {'id': 'TaizU-PP-AF-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional: Posterior Pericardiotomy', 'description': '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.', 'interventionNames': ['Procedure: Posterior Pericardiotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control: Standard Care', 'description': 'Conventional open-heart surgery is performed without posterior pericardiotomy. Standard perioperative care is provided.', 'interventionNames': ['Procedure: Standard Care']}], 'interventions': [{'name': 'Posterior Pericardiotomy', 'type': 'PROCEDURE', 'description': 'A longitudinal posterior pericardiotomy incision (4-5 cm) is made parallel and posterior to the left phrenic nerve during open-heart surgery.', 'armGroupLabels': ['Interventional: Posterior Pericardiotomy']}, {'name': 'Standard Care', 'type': 'PROCEDURE', 'description': 'Conventional open-heart surgery without posterior pericardiotomy. Standard perioperative care is provided.', 'armGroupLabels': ['Control: Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taiz', 'state': 'Muḩāfaz̧at Ta‘izz', 'country': 'Yemen', 'facility': 'Cardiovascular & Kidney Transplantation Centre, Taiz University, Taiz, Yemen', 'geoPoint': {'lat': 13.57952, 'lon': 44.02091}}], 'overallOfficials': [{'name': 'Ismail S Al Shameri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular & Kidney Transplantation Centre, Taiz University, Yemen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiz University - Faculty of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}