Heart Valve Diseases or ProsthesisNCT07251660
Comparison of Early Postoperative Outcomes Between Minimally Invasive Valve Surgery Via Right Thoracotomy and Conventional Valve Surgery Via Sternotomy.
A study testing Minimally Invasive Valve Surgery and Conventional Valve Surgery in people with Heart Valve Diseases or Prosthesis and Aortic Valve Stenosis, run by Chaudhry Pervaiz Elahi Institute of Cardiology.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Valve Diseases or Prosthesis, Aortic Valve Stenosis, Aortic Valve Insufficiency
- What is being tested?
- Minimally Invasive Valve Surgery and Conventional Valve Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of any age and gender.
- Undergoing elective, isolated mitral or aortic valve surgery.
- Considered suitable for either:
- MIVS via right thoracotomy, or
- Conventional valve surgery , as decided by the operating surgical team.
- Patients giving written informed consent.
Who cannot join
- Emergency or redo cardiac surgeries
- Concomitant cardiac procedures (e.g., CABG, multiple valve replacements)
- Ejection Fraction <30%
- Severe pulmonary hypertension (identified as the mean pulmonary artery pressure (mPAP) exceeding 45 mmHg on echocardiography, as outlined by the AHA guidelines(10).
- Active systemic infections or sepsis at the time of surgery
- Refusal to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Muhammad Hamid Senior Registrar, MBBS contact
About this study
Official title: Comparison of Early Postoperative Outcomes Between Minimally Invasive Valve Surgery Via Right Thoracotomy and Conventional Valve Surgery Via Sternotomy
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.
The 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.
Primary 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.
Read the detailed description
Valvular heart disease is a significant contributor to cardiovascular morbidity worldwide and often requires surgical intervention. Although median sternotomy provides excellent exposure for valve repair and replacement, it is associated with increased surgical trauma, prolonged recovery time, higher postoperative pain, and cosmetically visible scarring.
Minimally Invasive Valve Surgery (MIVS) through a right thoracotomy has emerged as a promising alternative approach, offering advantages such as smaller incisions, reduced postoperative discomfort, shorter hospitalization, and improved cosmetic outcomes-without compromising procedural safety. International evidence demonstrates comparable mortality and valve repair quality between the two techniques, with additional benefits favoring minimally invasive approaches such as reduced transfusion needs and fewer sternal wound complications. However, data from Pakistan remain sparse.
This randomized controlled trial is designed to evaluate the early postoperative outcomes of MIVS versus conventional sternotomy in a tertiary cardiac surgery center in Pakistan. Eligible patients undergoing elective, isolated mitral or aortic valve surgery will be randomized using a computer-generated sequence to one of two groups:
Group A (MIVS): Right anterolateral thoracotomy with femoral cannulation and transthoracic aortic clamping.
Group B (Sternotomy): Median sternotomy with standard central cannulation.
Both groups will receive standardized anesthesia, cardiopulmonary bypass protocols, myocardial protection strategies, and postoperative ICU care. The surgical procedures will be performed by experienced cardiac surgeons, and all perioperative variables will be recorded using a structured proforma.
Primary Outcomes
Cardiopulmonary bypass (CPB) time
Aortic cross-clamp time
Duration of mechanical ventilation
Postoperative pain score (NRS at 12 and 24 hours)
Total chest drain output in the first 24 hours
Secondary Outcomes
PRBC transfusion requirement
Wound condition on postoperative day 7
Echocardiographic findings before discharge and at 30 days
Return to routine daily activity by 30 days
30-day all-cause mortality
Patients will be followed for 30 days after surgery. Data will be analyzed using IBM SPSS v25. Continuous variables will be compared using an independent samples t-test, while categorical variables will be assessed via the Chi-square test. A p-value of <0.05 will be considered statistically significant.
This study aims to provide local evidence comparing the two surgical approaches and help determine whether minimally invasive valve surgery should be more widely adopted as a preferred option in tertiary cardiac surgical practice.
- Conditions
- Heart Valve Diseases or Prosthesis, Aortic Valve Stenosis, Aortic Valve Insufficiency, Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)
- Being tested
- Minimally Invasive Valve Surgery, Conventional Valve Surgery
- Keywords
- Heart valve disease, Mitral valve surgery Aortic valve surgery Minimally invasive cardiac surgery, Conventional open-heart surgery, Aortic cross-clamping, Early postoperative outcomes
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Gastroesophageal Reflux, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Valve SurgeryProcedure or 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.
Conventional Valve SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Minimally Invasive Valve Surgery |
| 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. Receives: Procedure: Conventional Valve Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Mechanical Ventilation
The duration of postoperative mechanical ventilation will be measured in hours from the time the patient arrives in the intensive care unit (ICU) after surgery until successful extubation. This outcome evaluates early recovery, respiratory function, and perioperative morbidity following minimally invasive valve surgery versus conventional sternotomy.
Measured: 24 hours
Secondary outcomes (8)
Cardiopulmonary Bypass Time
Total duration of cardiopulmonary bypass (CPB) measured in minutes from initiation to termination of bypass during surgery. This evaluates intraoperative efficiency and the impact of minimally invasive versus conventional surgical access on operative time.
Measured: During surgery
Aortic Cross-Clamp Time
Total duration in minutes during which the aorta is cross-clamped during cardioplegic arrest. This outcome assesses technical complexity and myocardial protection demands in each surgical approach.
Measured: During surgery
Chest Drain Output
Total volume of mediastinal and pleural drainage collected in the first 24 hours after surgery, measured in milliliters. This evaluates postoperative bleeding and tissue trauma associated with each surgical technique.
Measured: First 24 hours postoperatively
Postoperative Pain Score (NRS)
Pain intensity measured using the Numeric Rating Scale (0-10) at 12 hours and 24 hours postoperatively, assessing the effect of surgical access on postoperative comfort and recovery.
Measured: 12 hours and 24 hours after surgery
SSI on Postoperative Day 7
Assessment of the surgical wound for signs of erythema, discharge, infection, or dehiscence, classified as healthy or infected. This evaluates early wound healing differences between thoracotomy and sternotomy.
Measured: Postoperative day 7
SSI at 30-Day Follow-Up
Evaluation of wound healing and complications at 30 days after surgery, including infection, dehiscence, or healthy healing, assessed during outpatient follow-up.
Measured: 30 days postoperatively
Packed Red Blood Cell Transfusion Requirement
Number of units of packed red blood cells transfused within the first 24 hours after surgery, recorded to compare postoperative bleeding and transfusion needs.
Measured: First 24 hours postoperatively
30-Day All-Cause Mortality
Mortality due to any cause occurring within 30 days after surgery, including in-hospital or post-discharge events verified through medical records or contact with the patient's family.
Measured: Within 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve Diseases or ProsthesisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chaudhry Pervaiz Elahi Institute of Cardiology
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mujtaba A Siddiqui, Principal investigator, Chaudhary Pervaiz Elahi Institute of cardiology Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251660
- Sponsor's protocol ID
- CPEIC -321
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to the main study outcomes may be shared. This may include the anonymized dataset for ventilation time, postoperative pain scores, cardiopulmonary bypass time, cross-clamp time, chest drain output, wound condition assessments, transfusion requirements, echocardiographic follow-up findings, and 30-day outcomes. No identifiable data, images, or operative videos will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Postoperative Outcomes Between Minimally Invasive Valve Surgery Via Right Thoracotomy and Conventional Valve Surgery Via Sternotomy
- ClinicalTrials.gov ID
- NCT07251660
- Acronym / sponsor ID
- CPEIC -321
- Conditions
- Heart Valve Diseases or Prosthesis, Aortic Valve Stenosis, Aortic Valve Insufficiency, Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)
- Keywords
- Heart valve disease, Mitral valve surgery Aortic valve surgery Minimally invasive cardiac surgery, Conventional open-heart surgery, Aortic cross-clamping, Early postoperative outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Chaudhry Pervaiz Elahi Institute of CardiologyOther government
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 26 Nov 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.
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.
The 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.
Primary 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.
Detailed description
Valvular heart disease is a significant contributor to cardiovascular morbidity worldwide and often requires surgical intervention. Although median sternotomy provides excellent exposure for valve repair and replacement, it is associated with increased surgical trauma, prolonged recovery time, higher postoperative pain, and cosmetically visible scarring.
Minimally Invasive Valve Surgery (MIVS) through a right thoracotomy has emerged as a promising alternative approach, offering advantages such as smaller incisions, reduced postoperative discomfort, shorter hospitalization, and improved cosmetic outcomes-without compromising procedural safety. International evidence demonstrates comparable mortality and valve repair quality between the two techniques, with additional benefits favoring minimally invasive approaches such as reduced transfusion needs and fewer sternal wound complications. However, data from Pakistan remain sparse.
This randomized controlled trial is designed to evaluate the early postoperative outcomes of MIVS versus conventional sternotomy in a tertiary cardiac surgery center in Pakistan. Eligible patients undergoing elective, isolated mitral or aortic valve surgery will be randomized using a computer-generated sequence to one of two groups:
Group A (MIVS): Right anterolateral thoracotomy with femoral cannulation and transthoracic aortic clamping.
Group B (Sternotomy): Median sternotomy with standard central cannulation.
Both groups will receive standardized anesthesia, cardiopulmonary bypass protocols, myocardial protection strategies, and postoperative ICU care. The surgical procedures will be performed by experienced cardiac surgeons, and all perioperative variables will be recorded using a structured proforma.
Primary Outcomes
Cardiopulmonary bypass (CPB) time
Aortic cross-clamp time
Duration of mechanical ventilation
Postoperative pain score (NRS at 12 and 24 hours)
Total chest drain output in the first 24 hours
Secondary Outcomes
PRBC transfusion requirement
Wound condition on postoperative day 7
Echocardiographic findings before discharge and at 30 days
Return to routine daily activity by 30 days
30-day all-cause mortality
Patients will be followed for 30 days after surgery. Data will be analyzed using IBM SPSS v25. Continuous variables will be compared using an independent samples t-test, while categorical variables will be assessed via the Chi-square test. A p-value of <0.05 will be considered statistically significant.
This study aims to provide local evidence comparing the two surgical approaches and help determine whether minimally invasive valve surgery should be more widely adopted as a preferred option in tertiary cardiac surgical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive valve surgery via right thoracotomy | Experimental | Procedure: Minimally Invasive Valve SurgeryParticipants 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. |
| Conventional Valve Surgery via Median Sternotomy | Active comparator | Procedure: Conventional Valve SurgeryParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of any age and gender.
- Undergoing elective, isolated mitral or aortic valve surgery.
- Considered suitable for either:
- Patients giving written informed consent.
Key exclusion criteria (6 listed)
- Emergency or redo cardiac surgeries
- Concomitant cardiac procedures (e.g., CABG, multiple valve replacements)
- Ejection Fraction <30%
- Severe pulmonary hypertension (identified as the mean pulmonary artery pressure (mPAP) exceeding 45 mmHg on echocardiography, as outlined by the AHA guidelines(10).
- Active systemic infections or sepsis at the time of surgery
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 |
|---|---|---|
| Minimally Invasive Valve SurgeryParticipants 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. | Procedure or surgery | Minimally invasive valve surgery via right thoracotomy |
| Conventional Valve SurgeryParticipants 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. | Procedure or surgery | Conventional Valve Surgery via Median Sternotomy |
Primary outcome
Duration of Mechanical Ventilation
Time frame: 24 hours
The duration of postoperative mechanical ventilation will be measured in hours from the time the patient arrives in the intensive care unit (ICU) after surgery until successful extubation. This outcome evaluates early recovery, respiratory function, and perioperative morbidity following minimally invasive valve surgery versus conventional sternotomy.
8 secondary outcomes
Cardiopulmonary Bypass Time
Time frame: During surgery
Aortic Cross-Clamp Time
Time frame: During surgery
Chest Drain Output
Time frame: First 24 hours postoperatively
Postoperative Pain Score (NRS)
Time frame: 12 hours and 24 hours after surgery
SSI on Postoperative Day 7
Time frame: Postoperative day 7
SSI at 30-Day Follow-Up
Time frame: 30 days postoperatively
Packed Red Blood Cell Transfusion Requirement
Time frame: First 24 hours postoperatively
30-Day All-Cause Mortality
Time frame: Within 30 days postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to the main study outcomes may be shared. This may include the anonymized dataset for ventilation time, postoperative pain scores, cardiopulmonary bypass time, cross-clamp time, chest drain output, wound condition assessments, transfusion requirements, echocardiographic follow-up findings, and 30-day outcomes. No identifiable data, images, or operative videos will be shared.
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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.
Muhammad Hamid Senior Registrar, MBBS contact
Mujtaba A Siddiqui principal investigator
Chaudhary Pervaiz Elahi Institute of cardiology Multan
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Valve Surgery and Conventional Valve Surgery in people with Heart Valve Diseases or Prosthesis and Aortic Valve Stenosis, run by Chaudhry Pervaiz Elahi Institute of Cardiology.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Bilal Hassan Resident Cardiac Surgery, MBBS (+3006157734, garhamore88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Mechanical Ventilation (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2025.