Use of the Neovasc Coronary Sinus Reducer System for the Treatment of Refractory Angina Pectoris in Patients With Ngina Class 3-4 Who Are Not Candidates for Revascularization

Launched by TEL-AVIV SOURASKY MEDICAL CENTER · Mar 27, 2012

Keywords

ClinConnect Summary

This clinical trial is studying a device called the Neovasc Coronary Sinus Reducer System, which is designed for patients suffering from severe chest pain known as refractory angina. This type of angina occurs when heart-related chest pain persists even after receiving the best available medical treatments, and these patients are not suitable for surgical procedures to improve blood flow. To be eligible for the trial, participants must be at least 18 years old, have a specific level of chest pain (graded as Class III or IV), and show that their heart muscle isn't getting enough blood during stress tests.

If you or someone you know is considering participating, the trial is currently looking for volunteers aged 65 to 74. Participants will have the device implanted and will be monitored throughout the study to see if it helps reduce their chest pain. It’s important to note that certain medical conditions or recent heart issues may disqualify individuals from participating. Overall, this trial aims to explore a new treatment option for those who have been living with significant heart-related pain without other treatment options available.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • \>18 years old
• • Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society (CCS) grade III or IV despite attempted optimal medical therapy for thirty days prior to screening
• • Non-candidate for surgical or percutaneous coronary intervention, as determined by 2 independent Professors of Internal medicine
• • Reversible ischemia of the left ventricular wall demonstrated by Dobutamine Stress Echocardiography (Dobutamine ECHO; DSE), or by Thallium Spect
• Exclusion Criteria:
• • Recent (within three months) acute coronary syndrome
• • Recent (within six months) PCI or CABG
• • Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the thirty days prior to screening
• • De-compensated congestive heart failure or hospitalization due to CHF during the three months prior to screening
• • Life threatening rhythm disorders or any rhythm disorders that would require placement of an internal defibrillator and or pacemaker
• • Severe chronic obstructive pulmonary disease as indicated by a forced expiratory volume in one second that is less than 55% of the predicted value
• • Severe valvular heart disease
• • Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus
• • Patient having undergone tricuspid valve replacement or repair
• • Known allergy to stainless steel or nickel
• • Patient with anomalous or abnormal CS as demonstrated by angiogram. Abnormality defined as: Abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left SVC) and/or; CS diameter at the site of implantation\> 12mm