Status:
COMPLETED
Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction
Lead Sponsor:
Amir Lerman
Conditions:
Coronary Microvascular Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is being done to evaluate the role of a novel implantable device, called The Neovasc Reducer™ System, in improving microvascular function, symptoms and quality of life in symptomatic patien...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age \>18
- Able to provide written informed consent and willing to participate in all required study follow-up assessments
- Symptomatic CAD with refractory angina defined as CCS class II to IV, despite optimal tolerated medical therapy
- Abnormal coronary microvascular function indices: CFR≤2.5 and/or IMR≥25
- Exclusion Criteria
- Recent (within 3 months) acute coronary syndrome
- Patients with prior coronary artery bypass surgery
- Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the last 30 days
- Subjects in cardiogenic shock (systolic pressure \< 80mm/Hg, on vasopressors or intraaortic counter pulsation) at the time of consenting. Subjects who recover from cardiogenic shock by the time of consenting are eligible.
- Obstructive CAD on coronary angiography (\>70% stenosis or 50-70% stenosis with iFR\<0.89 or FFR\<0.8 in epicardial artery)
- Inability to perform invasive coronary flow evaluation and/or measure CFR and IMR in the LAD
- Severe valvular heart disease
- LVEF\<30%
- Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months
- Patient with a pacemaker electrode in the CS
- Mean right atrial pressure \>15 mmHg
- Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava (SVC) as demonstrated on angiogram
- CS diameter at the site of planned implantation greater than 13mm or less than 9.5 mm as measured by angiogram
- Severe chronic obstructive pulmonary disease (COPD) indicated by a forced expiratory volume in one second that is less than 55 percent of the predicted value
- Tricuspid valve replacement or repair (tissue or mechanical)
- Chronic renal failure (serum creatinine \>2mg/dL), and or on chronic hemodialysis
- Moribund, or with comorbidities limiting life expectancy to less than one year
- Known severe reaction to required procedural medication
- Known allergy to stainless steel or nickel
- Magnetic Resonance Imaging (MRI) within 8 weeks of Reducer implantation
- Participation in another ongoing investigational trial
- Additional factors deemed unsuitable for trial enrollment per discretion of principal investigator
- Inmates
Exclusion
Key Trial Info
Start Date :
June 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04523168
Start Date
June 28 2021
End Date
July 28 2023
Last Update
August 20 2024
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905