Trials / Unknown
UnknownNCT04892537
Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Imperial College London · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
ORBITA-COSMIC is a randomised, double-blinded, placebo controlled trial of the coronary sinus reducer (CSR). The investigators will compare the effects of CSR versus placebo on myocardial perfusion on MRI, exercise time and symptoms in 50 participants with refractory angina and ischaemia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Coronary Sinus Reducer | Coronary Sinus Reducer implantation according to standard clinical protocols |
| PROCEDURE | Placebo Procedure | A placebo procedure involving venous sheath implantation in the right internal jugular vein without proceeding to CSR implantation |
Timeline
- Start date
- 2021-05-21
- Primary completion
- 2024-01-01
- Completion
- 2024-01-01
- First posted
- 2021-05-19
- Last updated
- 2023-10-30
Locations
5 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04892537. Inclusion in this directory is not an endorsement.