Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure (NCT07057323) | Clinical Trial Compass
By InvitationNot Applicable
Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure
United States35 participantsStarted 2025-10-16
Plain-language summary
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, specifically invasive measurement of PAWP during standardized exercise.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Age ≥ 18
* Able to provide written informed consent and willing to participate in all required study follow-up assessments
* Clinical indicated coronary angiography with invasive CRT testing within 9 months prior to enrollment. Abnormal CFR of ≤ 2.5
* Symptomatic HFpEF defined by (PAWP\>15mmHg at rest and /or PAWP\>25 mmHg on exertion) during clinically performed Right heat catheterization with exercise performed within 6 months of enrollment or during screening visit (if not performed clinically in the last 6 months).
* Non-Obstructive CAD (≤ 50% stenosis in epicardial vessels and/or iFR\>0.89 or FFR\>0.8 in vessels with 50 to 70% stenosis)
Exclusion Criteria
* History of left ventricular (LV) ejection fraction \<50%
* Significant epicardial CAD (angiographic stenosis ≥70% or positive FFR or iFR in any major epicardial coronary artery
* Significant valvular heart disease (more than moderate regurgitation and or stenosis)
* Primary cardiomyopathies (hypertrophic, infiltrative or restrictive)
* Constrictive pericarditis
* Severe myocardial bridging
* Stiff left atrial syndrome
* Pregnancy
* Recent (with 3 months) acute coronary syndrome
* Subjects in Cardiogenic shock (systolic pressure\<80mm/Hg)
* NYHA Class III or IV heart failure decompensated HF
* Mean right atrial pressure at rest \>15 mmHg
* Anomalous or abnormal CS anatomy (e.g. tortuosity aberrant branch persistent left superior vena cava as demonstrated on angiogram
* CS diameter at the site of…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pulmonary Arterial Wedge Pressure (PAWP) at exercise