Coronary Sinus Reducer for Heart Failure

Overseen By Diana Albers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Heart failure, Cardiomyopathies, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called the Coronary Sinus Reducer (a medical device) to determine its effectiveness for individuals with HFpEF (heart failure with preserved ejection fraction) and CMD (coronary microvascular dysfunction). Researchers aim to discover if this treatment can enhance the heart's ability to manage blood flow during exercise. Suitable candidates for this trial experience heart failure symptoms related to heart function and have been diagnosed with non-obstructive coronary artery disease, meaning their arteries aren't severely blocked. Individuals with heart failure but normal heart pumping ability may find this trial relevant. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for heart failure patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Coronary Sinus Reducer is safe for heart failure patients?

Research has shown that the Coronary Sinus Reducer is generally safe for patients. Studies have found that patients tolerate this device well, and it helps reduce chest pain caused by heart issues. Real-world data suggests that the procedure to implant the device rarely leads to serious side effects. Most patients experience improvements in their condition and quality of life. While all treatments carry some risks, past research has demonstrated a promising safety record for the Coronary Sinus Reducer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Coronary Sinus Reducer is unique because it offers a new approach for treating heart failure with preserved ejection fraction (HFpEF), a condition where current treatments like diuretics and beta-blockers often offer limited relief. Unlike these standard treatments, which primarily manage symptoms, the Coronary Sinus Reducer works by altering blood flow in the heart's veins, potentially improving heart function directly. Researchers are excited because this device could address the underlying issues in HFpEF, offering hope for better quality of life for patients who haven't found success with existing options.

What evidence suggests that the Coronary Sinus Reducer is effective for heart failure?

Research has shown that the Coronary Sinus Reducer benefits heart failure patients, particularly those with preserved ejection fraction (HFpEF). Studies have found the procedure succeeds 98.3% of the time, indicating the device almost always functions as intended. Patients have reported symptom improvements, suggesting enhanced heart function. Real-world evidence confirms its safety and effectiveness, making it a promising option for this type of heart failure. Overall, the CS Reducer helps manage heart conditions by reducing heart pressure, alleviating symptoms, and improving quality of life. ^{1 2 3 6 7}

Who Is on the Research Team?

Amir Lerman

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure who have non-obstructive coronary artery disease, can consent to the study, and have had certain heart tests within the last 6 months. It's not for pregnant individuals, those with severe kidney issues or life expectancy less than a year, people with pacemakers in the coronary sinus, or anyone allergic to stainless steel or nickel.

Inclusion Criteria

Non-Obstructive CAD (≤ 50% stenosis in epicardial vessels and/or iFR>0.89 or FFR>0.8 in vessels with 50 to 70% stenosis)

Able to provide written informed consent and willing to participate in all required study follow-up assessments

I am 18 years old or older.

Exclusion Criteria

Pregnancy

My kidney function is impaired with high creatinine levels.

Inmates

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

CS Reducer implantation and monitoring of left ventricular filling pressures during exercise

6 months

Multiple visits for right heart catheterization and exercise testing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Coronary Sinus Reducer

Trial Overview The trial is testing a Coronary Sinus Reducer implant in patients with symptomatic heart failure to see if it helps lower left ventricular filling pressures during exercise. This involves an invasive measurement of pulmonary artery wedge pressure (PAWP) during standardized exercise.

How Is the Trial Designed?

Group I: Heart failure with a preserved ejection fraction (HFpEF) Experimental Treatment 1 Intervention

Subjects with diagnosed Heart failure with a preserved ejection fraction (HFpEF), non-obstructive Coronary Artery Disease (CAD), and have documented CMD.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Shockwave Medical, Inc.

Industry Sponsor

Trials

38

Recruited

10,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07057323

Study Details | NCT07057323 | Coronary Sinus Reducer ... The purpose of this study is to evaluate the efficacy of CS Reducer implantation in patients with HFpEF and CMD on left ventricular filling pressures, ...

2. jacc.org jacc.org/doi/10.1016/j.jcin.2025.06.012

Safety, Efficacy, and Effectiveness of Coronary Sinus ... The overall unweighted procedural success rate was 98.3% (95% CI: 97.0%-99.1%). Single-arm studies and RCT intervention arms demonstrated ...

3. withpower.com withpower.com/trial/phase-heart-failure-with-preserved-ejection-fraction-hfpef-7-2025-c5a85

Coronary Sinus Reducer for Heart Failure The purpose of this study is to evaluate the efficacy of CS Reducer implantation in patients with HFpEF and CMD on left ventricular filling pressures, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11313317/

Safety and Effectiveness of Coronary Sinus Reducer in the ... Data from our real-world, single-center registry appear to confirm that CS reducer implantation is a safe and effective therapeutic option for patients with ...

5. patlynk.com patlynk.com/trial/NCT07057323

Coronary Sinus Reducer for Symptomatic Heart Failure ... This study focuses on evaluating a treatment device called the CS Reducer for people who have a type of heart failure known as HFpEF, which means heart ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S193687982501653X

Safety, Efficacy, and Effectiveness of Coronary Sinus ... Limitations of the New York Heart Association functional classification system and self-reported walking distances in chronic heart failure.

7. bmccardiovascdisord.biomedcentral.com bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-025-04617-8

The efficacy and safety of coronary sinus reducer in refractory ... CSR appears to be a safe and effective treatment for refractory angina, providing significant improvements in symptoms and quality of life.