Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Intuitive Surgical India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects deemed suitable for surgery based on clinical judgment, who have independently chosen to undergo either robotic-assisted or open bilateral IMA harvest with CABG for multivessel disease, and who have a EuroSCORE II of less than or equal to 4% as assessed by the Investigator. 2. Subjects of either sex, aged greater than or equal to 18 years, and capable of understanding, reading, and writing English. 3. Subjects willing and able to provide written, signed, and dated informed consent.
Exclusion criteria
Exclusion criteria: 1. Contraindication to general anesthesia or the planned surgical procedure 2. Emergency or redo cardiac surgery, including prior major cardiac surgery involving pericardiotomy. 3. Planned concomitant surgical procedures. 4. Pregnancy or suspected pregnancy. 5. Any physical or mental condition that may compromise the ability to provide informed consent, comply with study requirements, or complete follow-up. 6. Participation in another investigational study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Life AssessmentTimepoint: Pre-Operative Assessment (-7 days), Post-Operative Assessment at day 7+2 day, Post-Operative Assessment at day 14+3 day, Day 30 (+5 days), and optional long-term follow-up at 3 Months (+/- 15 Days) and 12 Months (+/- 30 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-operative PainTimepoint: Pre-Operative Assessment (-7 days), Intra-operative Assessment, Post-Operative Assessment up to Discharge, and Post-Operative Assessment at day 7 day;Length of Hospital Stay (LOS)Timepoint: Surgery to Discharge;Safety Profile of Individual Surgical ProcedureTimepoint: Intra-operative and Post-operative up to 30 days | — |
Countries
India
Contacts
Public ContactDr Akhil Dahiya
Intuitive Surgical India Private Limited
Outcome results
None listed