NCT04121845

CoROnary SinuS Reducer implantatiOn for ischemiA reDuction

The Influence of Coronary Sinus Reducer Implantation on Exertional Capacity, Extent of Myocardial Ischemia and hrECG Markers of Arrhythmogenicity in Patients With Refractory Angina Pectoris

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Patients with refractory angina pectoris have low quality of life and reduced exertional capacity. Studies have shown that the coronary sinus reducer (CSR) implantation improves the quality of life. However, to date there are no firm objective data on improvement of exertional capacity. Studies have shown a large influence of placebo effect after interventional procedures, which is even more pronounced than in medically treated patients. As angina pectoris presents entirely subjective perception of chest discomfort, its improvement may be influenced by this effect in up to 30 %. The investigators will study weather the CSR implantation improves aerobic exertional capacity in comparison to optimal medical therapy alone. Further, the investigators will explore the extent of myocardial reversible ischemia reduction and possible influence on hrECG markers of left ventricular arrhythmogenicity. 40 patients with refractory angina CCS class (Canadian cardiovascular society) II-IV and confirmed reversible ischemia will be included. Patients will be randomized into two groups. The first group will undergo CSR implantation procedure. The second group will present a sham control group with placebo procedure. At inclusion and after 6 months the investigators will perform cardiopulmonary exercise test (CPET), single photon emission tomography for detection of reversible ischemia (SPECT), high resolution ECG (hrECG), echocardiography and asses the subjective burden of angina according to CCS score and the quality of life according to the Seattle angina Questionnaire (SAQ).

Conditions

• Refractory Angina Pectoris

Interventions

Type	Name	Description
DEVICE	Coronary Sinus Reducer device	Coronary sinus reducer device (Neovasc, Richomnd, Canada) implantation in the coronary sinus. The procedure is performed in the cardiac catheterization laboratory through right internal jugular vein.
OTHER	Sham procedure	Puncture of the right internal jugular vein and simulation of the CSR implantation procedure.

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-12-31
• Completion: 2022-06-30
• First posted: 2019-10-10
• Last updated: 2022-07-25

Locations

1 site across 1 country: Slovenia