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:
* 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 or PET with CRF assessment prior to enrollment. Abnormal CFR of ≤ 2.5 or PET CFR ≤ 2.0
* Symptomatic HFpEF defined by (PAWP\>15mmHg at rest and /or PAWP\>25 mmHg on exertion) during clinically performed Right heat catheterization with exercise performed prior to enrollment or during screening visit (if not performed clinically ).
* 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:
* Significant epicardial CAD (angiographic stenosis ≥70% or positive FFR or iFR in any major epicardial coronary artery
* Significant valvular heart disease moderate to severe regurgitation and or stenosis)
* Primary cardiomyopathies (hypertrophic, infiltrative or restrictive)
* Constrictive pericarditis
* Severe myocardial bridging
* Pregnancy
* Recent (with 3 months) acute coronary syndrome
* Subjects in Cardiogenic shock (systolic pressure\<80mm/Hg)
* 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 planned implantation greater than 13mm or less than 9.5 mm as measured by angiogram.
* Known severe reaction to required procedural medications
* Known a…
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.
1This trial uses a device called a Coronary Sinus Reducer — can you explain how narrowing the coronary sinus is supposed to help my heart failure with preserved ejection fraction, and whether that mechanism makes sense for my specific situation?
2The main thing this trial is measuring is how the device affects the pressure in my lungs during exercise — what does that mean for what we'd actually learn from this study, and is that a good indicator of whether I might feel better day-to-day?
3Since this trial is 'enrolling by invitation only,' how would I even be considered for it, and do you think my current condition and test results would make me a plausible candidate worth discussing with the trial team?
4Because this is listed as Phase NA, it sounds like it may involve a device study rather than a traditional drug trial — what does that mean for how much is already known about the safety of this device in heart failure patients like me?
5Before considering a device-based study like this, would it make sense for me to first try or optimize any standard heart failure treatments, or do you think this trial could be worth exploring alongside what I'm already doing?
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