CoROnary SinuS Reducer implantatiOn for ischemiA reDuction

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Refractory Angina Pectoris

Intervention / Treatment
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* Device: Coronary Sinus Reducer device
* Other: Sham procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: angina pectoris CCS class II-IV receiving optimal medical therapy for at least one month confirmed reversible myocardial ischemia in left anterior descending coronary artery (LAD) and/or left circumflex coronary artery (LCX) territory by SPECT not candidate for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) Exclusion Criteria: recent non stable angina pectoris (within 1 months) recent acute coronary syndrome (within 3 months) recent successful PCI and/or CABG (within 6 months) decompensated heart failure and/or recent (within 3 months) hospitalization due to heart failure severe heart valve(s) disease advanced chronic obstructive pulmonary disease (COPD) or poorly managed asthma peripheral arterial disease, musculoskeletal disorder or central nervous system disease which preclude exercise testing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>Coronary sinus reducer implantation through right internal jugular vein. | Device: Coronary Sinus Reducer device<br>* 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.<br>|
| Sham Comparator: Sham group<br>Puncture of the right internal jugular vein and simulation of the CSR implantation procedure. | Other: Sham procedure<br>* Puncture of the right internal jugular vein and simulation of the CSR implantation procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of CSR versus placebo procedure on exertional capacity measured by maximal oxygen consumption (VO2) during cardio-pulmonary exercise testing. | Maximal oxygen consumption on cycle spiroergometry using the same ramp exercise protocol during the same part of the day. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of CSR versus placebo procedure on exercise duration time during cardio-pulmonary exercise testing. | Exercise duration time on cycle spiroergometry using the same continuous exercise protocol during the same part of the day. | 6 months | 
| Change in the extent of myocardial reversible ischemia calculated by single-photon emission computed tomography (dynamic scintigraphy). | Dynamic myocardial scintigraphy with the use of a 4 segment model of the left ventricle for calculation of absolute regional perfusion (ml/g/min) during rest and during pharmacologic stress. Change in the extent of myocardial reversible ischemia calculated by single-photon emission computed tomography. | 6 months | 
| Change in the extent of myocardial reversible ischemia calculated by single-photon emission computed tomography (static scintigraphy). | Static myocardial scintigraphy with the use of a 17 segment model for the relative calculation of regional perfusion during rest and pharmacologic stress. | 6 months | 
| Change in RR interval variability as assessed by hrECG. | 5 min recording of hrECG (1000 Hz) for the calculation of RR interval variability. | 6 months | 
| Change in late potentials as assessed by hrECG. | 5 min recording of hrECG (1000 Hz) for the calculation of late potentials. | 6 months | 
| Change in QT variability as assessed by hrECG. | 5 min recording of hrECG (1000 Hz) for determination of QT variability. | 6 months | 
| Change in Canadian Cardiovascular Society angina pectoris class (CCS). | Change in CCS class I-IV. Acco | 3 months, 6 months | 
| Impact of CSR versus placebo procedure on quality of life according to Seattle angina questionnaire (SAQ). | Change in each of the five categories: Physical Limitation Scale (range 1-100), Anginal Stability Scale (range 1-100), Anginal Frequency Scale (range 1-100), Treatment Satisfaction Scale (range 1-100), Disease Perception Scale (range 1-100). Higher values in scale represent better outcome. Subscales are not combined. | 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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angina pectoris, coronary sinus reducer, quality of life, reversible ischemia, exercise testing, oxygen consumption