[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612290":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":45,"collaborators":26,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":26,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":26,"maxAge":26,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":73,"whyStopped":26,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":26},{"fullName":5,"class":6},"Chaudhry Pervaiz Elahi Institute of Cardiology","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Minimally invasive valve surgery via right thoracotomy","EXPERIMENTAL","Participants in this arm will undergo minimally invasive valve surgery through a right anterolateral thoracotomy. Cardiopulmonary bypass will be established via femoral arterial and venous cannulation. A transthoracic aortic cross-clamp will be used, and the mitral or aortic valve will be repaired or replaced using standard minimally invasive techniques. This approach uses a smaller incision, avoids median sternotomy, and aims to reduce postoperative pain, ventilation time, and wound complications.",[13],"Procedure: Minimally Invasive Valve Surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Valve Surgery via Median Sternotomy","ACTIVE_COMPARATOR","Participants in this arm will undergo conventional open-heart valve surgery through a full median sternotomy. Cardiopulmonary bypass will be established with aortic and right atrial cannulation. Cold-blood cardioplegia will be administered antegrade, and the diseased valve will be accessed and either replaced or repaired via standard surgical exposure. This approach represents the established conventional method used for valvular surgery.",[19],"Procedure: Conventional Valve Surgery",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Minimally Invasive Valve Surgery","Participants in this group will undergo minimally invasive valve surgery through a right anterolateral thoracotomy. A small 5-7 cm incision will be made in the 4th or 5th intercostal space. Cardiopulmonary bypass will be established using femoral arterial and venous cannulation. A transthoracic aortic cross-clamp will be applied, and cold blood cardioplegia will be administered. The mitral or aortic valve will be accessed through limited thoracic exposure and repaired or replaced using standard techniques. This approach avoids median sternotomy and aims to reduce postoperative pain, ventilation time, transfusion needs, and wound complications.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional Valve Surgery","Participants in this group will undergo conventional open-heart valve surgery through a full median sternotomy. Cardiopulmonary bypass will be established using aortic and right atrial cannulation. Standard antegrade cold blood cardioplegia will be administered for myocardial protection. The mitral or aortic valve will be exposed through full sternal access and repaired or replaced following established institutional protocols. This approach represents the traditional surgical method used for valvular heart disease.",[15],[32],{"name":33,"affiliation":34,"role":35},"Mujtaba A Siddiqui","Chaudhary Pervaiz Elahi Institute of cardiology Multan","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Dr Bilal Hassan Resident Cardiac Surgery, MBBS","CONTACT","+3006157734","garhamore88@gmail.com",{"name":43,"role":39,"phone":26,"phoneExt":26,"email":44},"Muhammad Hamid Senior Registrar, MBBS","dr.hamid632@gmail.com",{"type":46,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100612290","comparison-of-early-postoperative-outcomes-between-minimally-invasive-valve-surgery-via-right-thoracotomy-and-conventional-valve-surgery-via-sternotomy-100612290",false,"NCT07251660","Comparison of Early Postoperative Outcomes Between Minimally Invasive Valve Surgery Via Right Thoracotomy and Conventional Valve Surgery Via Sternotomy.","Comparison of Early Postoperative Outcomes Between Minimally Invasive Valve Surgery Via Right Thoracotomy and Conventional Valve Surgery Via Sternotomy","Inclusion Criteria:\n\n* Patients of any age and gender.\n* Undergoing elective, isolated mitral or aortic valve surgery.\n* Considered suitable for either:\n\n  * MIVS via right thoracotomy, or\n  * Conventional valve surgery , as decided by the operating surgical team.\n* Patients giving written informed consent.\n\nExclusion Criteria:\n\n* Emergency or redo cardiac surgeries\n* Concomitant cardiac procedures (e.g., CABG, multiple valve replacements)\n* Ejection Fraction \\\u003C30%\n* Severe pulmonary hypertension (identified as the mean pulmonary artery pressure (mPAP) exceeding 45 mmHg on echocardiography, as outlined by the AHA guidelines(10).\n* Active systemic infections or sepsis at the time of surgery\n* Refusal to participate in the study","ALL",{"count":56,"type":57},32,"ESTIMATED","INTERVENTIONAL",[60],"NA","This randomized controlled trial aims to compare early postoperative outcomes between Minimally Invasive Valve Surgery (MIVS) via right thoracotomy and Conventional Valve Surgery via median sternotomy in patients undergoing elective, isolated mitral or aortic valve surgery. Minimally invasive techniques are believed to reduce postoperative pain, ventilation time, chest drain output, and wound complications, but evidence from Pakistan is limited.\n\nThe study will enroll patients of all ages and genders who are scheduled for isolated valvular procedures at Chaudhary Pervaiz Elahi Institute of Cardiology (CPEIC), Multan. Participants will be randomly assigned to undergo either minimally invasive thoracotomy or conventional sternotomy.\n\nPrimary outcomes include ventilation time, CPB duration, cross-clamp time, pain scores, and chest drain output. Secondary outcomes include wound healing (Day 7 and 30 days), return to routine activity, echocardiographic evaluation, transfusion requirements, and 30-day mortality. Findings from this study may provide evidence to guide the adoption of minimally invasive valvular surgery techniques in low-resource and developing settings.",[63,64,65,66],"Heart Valve Diseases or Prosthesis","Aortic Valve Stenosis","Aortic Valve Insufficiency","Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)",[68,69,70,71,72],"Heart valve disease","Mitral valve surgery Aortic valve surgery Minimally invasive cardiac surgery","Conventional open-heart surgery","Aortic cross-clamping","Early postoperative outcomes","NOT_YET_RECRUITING","2025-11-19",{"date":76,"type":77},"2025-11-26","ACTUAL",{"date":79,"type":57},"2025-12-15",{"date":81,"type":57},"2026-08-15",{"name":5,"class":6}]