Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance (ORBITA-COSMIC)

Imperial College London

Status: Enrolling

Conditions: Refractory Angina

Treatments: Device: Coronary Sinus Reducer; Procedure: Placebo Procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04892537

20HH6457

MR/V001620/1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable coronary artery disease (CAD) not eligible for percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG)
• Evidence of ischaemia on stress perfusion CMR
• Angina - Canadian Cardiovascular Society Class II-VI on maximal medical therapy

Exclusion criteria

• Age<18 years
• Pregnancy
• Inability to consent
• Recent acute coronary syndrome (3 months)
• Recent revascularisation (6 months)
• Permanent pacemaker or defibrillator leads in the right heart
• Severe left ventricular impairment (<25%)
• Indication for cardiac resynchronisation therapy (CRT)
• Right atrial pressure ≥15mmHg
• Life expectancy <1 year
• Severe renal impairment (eGFR<15)
• Contraindication to CMR
• Contraindication to adenosine
• Ischaemia isolated to inferior wall
• Ongoing participation in a separate interventional study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

CSR

Active Comparator group

Description:

Coronary Sinus Reducer implantation

Treatment:

Device: Coronary Sinus Reducer

Placebo

Placebo Comparator group

Description:

Placebo procedure

Treatment:

Procedure: Placebo Procedure