Tests a device for chest pain from poor heart blood flow in adults
Tests an implanted device in adults with severe chest pain from heart disease.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Tel Aviv, IsraelSee the 2 sites
Where in Israel
- Tel Aviv Medical CenterTel Aviv, IsraelTaking people
- Tel-Aviv Sourasky Medical CenterTel Aviv, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tel-Aviv Sourasky Medical Center
- Trial code
- NCT01566175
- Record updated
- 2 February 2022
- Original description
The purpose of this study is to implant the Reducer in patients with the symptoms of refractory angina, that suffer from refractory angina who demonstrate reversible ischemia.Read full original descriptionShow less
Use of the Neovasc Coronary Sinus Reducer System for the Treatment of Refractory Angina Pectoris in Patients With Angina Class 3-4 Who Are Not Candidates for Revascularization
The purpose of this study is to implant the Reducer in patients with the symptoms of refractory angina, that suffer from refractory angina who demonstrate reversible ischemia.
Inclusion: >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: 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; Recent (within three months) acute coronary syndrome; 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; Known allergy to stainless steel or nickel; Recent (within six months) PCI or CABG; Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus; Patient having undergone tricuspid valve replacement or repair; 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.