Actively Recruiting
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
Led by Tel-Aviv Sourasky Medical Center · Updated on 2022-02-02
100
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
Tel-Aviv Sourasky Medical Center
Lead Sponsor
S
Shockwave Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the use of the Neovasc Coronary Sinus Reducer device in patients suffering from refractory angina who have advanced obstructive coronary artery disease and severe symptoms despite optimal medical treatment. These patients are not candidates for surgical or percutaneous revascularization. The study focuses on those with reversible ischemia and aims to reduce angina episodes and improve quality of life in this difficult-to-treat population. Participants will receive the Neovasc coronary sinus reducer device through an open-label procedure. This device is implanted in the coronary sinus and has been previously used in a limited number of patients with promising safety data up to three years. The procedure carries theoretical risks similar to pacemaker electrode insertion but has not shown procedure-related adverse events in prior studies. The goal is to reduce angina severity, improve heart function, and decrease reliance on medications and healthcare visits. During the study, participants will be monitored for changes in their angina severity using the Canadian Cardiovascular Society Angina Score over six months. Researchers will assess symptoms, quality of life, and heart function improvements. The study includes detailed follow-up visits and evaluations to track safety and effectiveness of the device. Total participation duration and ongoing monitoring details are determined by the study protocol.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years old
- Symptomatic coronary artery disease with chronic refractory angina class III or IV despite optimal medical therapy for at least 30 days prior to screening
- Not a candidate for surgical or percutaneous coronary intervention as confirmed by two independent doctors
- Reversible ischemia of the left ventricular wall shown by Dobutamine Stress Echocardiography or Thallium Scan
You will not qualify if you...
- Acute coronary syndrome within the last 3 months
- Percutaneous coronary intervention or coronary artery bypass graft surgery within the last 6 months
- Unstable angina or recent onset angina with ECG changes within 30 days prior to screening
- Decompensated congestive heart failure or hospitalization for heart failure within 3 months prior to screening
- Life-threatening or device-requiring heart rhythm disorders
- Severe chronic obstructive pulmonary disease with lung function less than 55% predicted
- Severe valvular heart disease
- Presence of pacemaker or defibrillator electrodes in the right atrium, right ventricle, or coronary sinus
- Previous tricuspid valve replacement or repair
- Known allergy to stainless steel or nickel
- Abnormal coronary sinus anatomy or diameter greater than 12mm at implantation site shown by angiogram
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate recovery
Participants receive the Neovasc coronary sinus reducer device implanted to treat refractory angina.
1 implantation visit (in-person)
Duration - Up to 6 months
Participants are monitored to assess the effectiveness and safety of the device over time.
Multiple follow-up visits over 6 months
Trial Site Locations
Total: 2 locations
1
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
2
Tel Aviv Medical Center
Tel Aviv, Israel
Actively Recruiting
Research Team
S
Shmuel Banai, Prof.
G
Gad Keren, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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