New device aims to unclog the Heart's drain for stubborn heart failure patients
NCT ID NCT07057323
First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This study tests a small device, called the Coronary Sinus Reducer, in 35 people with a type of heart failure where the heart pumps well but still has trouble filling with blood. The device is placed in a vein of the heart to help lower pressure during exercise. The goal is to see if it improves symptoms and quality of life.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 allergy to stainless steel or nickel * Magnetic Resonance Imaging (MRI) within 8 weeks after Reducer implantation * Chronic renal failure (serum creatinine\>2mg/dL) * Severe chronic obstructive pulmonary disease (COPD) as indicated by forced expiratory volume in one second that is less than 55% of the predicted value or need for home daytime oxygen * Pacemaker electrode/lead in the coronary sinus * Moribund or with comorbidities limiting life expectancy to less than one year * Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention. * Inability or unwillingness of individual to give written informed consent. * Additional factors deemed unsuitable for trial enrollment per discretion of the Principal Investigator * Inmates
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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Other studies related to the condition(s) this trial covers.
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