An Evaluation of Patient Reported Outcomes and Clinical Outcomes
Purpose
This extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery: - Patient reported outcomes (PRO), using the EQ-5D questionnaire - Clinical outcomes
Condition
- Post-Operative Complications in Cardiac Surgery
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Subjects must have completed the REN-007 study to be eligible to participate in the Extension Study.
Exclusion Criteria
- Subjects who did not complete the REN-007 study are not eligible to participate in the Extension Study. - Female subjects who become pregnant during the REN-007 study are not eligible to participate in the Extension Study.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| RBT-1 | Patients undergoing CABG, valve, or combined CABG/valve surgery |
|
| Placebo | Patients undergoing CABG, valve, or combined CABG/valve surgery |
|
Recruiting Locations
More Details
- NCT ID
- NCT06092970
- Status
- Active, not recruiting
- Sponsor
- Renibus Therapeutics, Inc.