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Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance

NCT04892537 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-10-30

No results posted yet for this study

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

  • Refractory Angina

Interventions

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

Sponsors & Collaborators

  • Medical Research Council

    collaborator OTHER_GOV

  • Imperial College Healthcare Nissen Fund

    collaborator UNKNOWN

  • Imperial College London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04892537 on ClinicalTrials.gov