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A study to compare the early and long term results following routine surgical incision versus minimal surgical incision for heart valve replacement surgery

Early and long term outcomes following minimally invasive single valve (Aortic or Mitral) replacement versus conventional single (Aortic or Mitral) valve replacement â?? A randomized open label trial - MIVR trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027018
Enrollment
380
Registered
2020-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I083- Combined rheumatic disorders of mitral, aortic and tricuspid valves

Interventions

Intervention1: Minimally invasive valve replacement: Valve replacement (Mitral or Aortic) is done by a small incision - Anterolateral thoracotomy /Mini sternotomy for Mitral valve and Right second spa

Sponsors

Science and Engineering Research Board SERB
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Consecutive consenting patients aged more than or equal to 18 years and who undergo mitral or aortic valve replacement with or without tricuspid valve repair in the Department of Cardiothoracic and vascular surgery (CTVS) in our institute

Exclusion criteria

Exclusion criteria: i) Patients undergoing double valve/tricuspid valve replacement ii) Patients undergoing redo-valve replacements iii)Patients requiring concomitant coronary artery bypass (CABG) along with valve replacement

Design outcomes

Primary

MeasureTime frame
Early - pain score by visual analog scoring, assisted ventilation time, number of blood products used, complications, duration of postoperative stay, in-hospital mortality Late- Wound or valve related complications, chronic surgical scar pain, mortalityTimepoint: Early - post operative period (postoperative day 0 till discharge, usually 7 days) Late- 6 months postoperative

Secondary

MeasureTime frame
Aortic cross clamp time and cardiopulmonary bypass timeTimepoint: Intraoperatively

Countries

India

Contacts

Public ContactDr Hemachandren Munuswamy

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

mhchandren@gmail.com9843220545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026