Heart Failure Preserved Ejection FractionNCT07057323
Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure
A study testing Coronary Sinus Reducer in people with Heart Failure Preserved Ejection Fraction, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure Preserved Ejection Fraction
- What is being tested?
- Coronary Sinus Reducer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure With A Preserved Ejection Fraction Associated With Coronary Microvascular Dysfunction
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.
- Being tested
- Coronary Sinus Reducer
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Sinus ReducerDevice
Subjects will have the Coronary Sinus Reducer implanted in their coronary sinus during a right heart catheterization procedure.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure with a preserved ejection fraction (HFpEF) | Experimental | Subjects with diagnosed Heart failure with a preserved ejection fraction (HFpEF), non-obstructive Coronary Artery Disease (CAD), and have documented CMD. Receives: Device: Coronary Sinus Reducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulmonary Arterial Wedge Pressure (PAWP) at exercise
Pulmonary Arterial Wedge Pressure (mmHg) is a measure of cardiac filling pressure. PAWP will be determined by a right heart catheterization at 20W exercise.
Measured: Baseline, 6 months
Secondary outcomes (13)
Change in Kansas City Cardiomyopathy (KCCQ-12)
KCCQ is a 12-item questionnaires that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. Scores were generated for each domain and scaled from 0 to 70, with 0 (worst) and 70 (the best possible status), where the higher score reflected better health status.
Measured: Baseline, 30 Days, 60 Days, 90 Days, 6 months
Change in Seattle Angina Questionnaire (SAQ)
Seattle Angina Questionnaire (SAQ) is a 19-item questionnaire that assesses 5 different scales: physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception. A higher score indicates a worse health status.
Measured: Baseline, 30 Days, 60 Days, 90 Days, 6 months
Change in New York Heart Association (NYHA) classification
New York Heart Association (NYHA) classification is used to classify patients into 4 categories based on their Heart Failure Symptoms. There are 4 classifications (1-4), a higher classification indicates a higher severity of Heart Failure symptoms.
Measured: Baseline, 6 months
Change in Canadian Cardiovascular Society (CCS)
Canadian Cardiovascular Society (CCS) is a classification system (1-4) used to determine severity of angina pectoris. A higher classification indicates higher severity of angina pectoris.
Measured: Baseline, 30 Days, 60 Days, 90 Days, 6 months
Change in Borg maximal perceived exertion scores
Borg CR10 Scale is a scale that ranges from 0-12. It is used to determine maximal perceived exertion. This will be measured at exercise during a right heart catheterization.
Measured: Baseline, 6 months
Change in maximum exercise capacity (VO2 max) during supine exercise testing
Maximum exercise capacity (VO2 max) is the maximum oxygen absorbed during exercise. VO2 max will be determined at exercise during right heart catheterization and measured in ml/kg/min.
Measured: Baseline, 6 months
Change in transcardiac lactate release
Transcardiac lactate release will be determined by blood sample and measured in mmol/L.
Measured: Baseline, 6 months
Change in transcardiac lactate uptake
Transcardiac lactate uptake will be determined by blood sample and measured in mmol/L.
Measured: Baseline, 6 months
Change in Pulmonary Arterial Wedge Pressure (PAWP) at rest
Pulmonary Arterial Wedge Pressure (mmHg) is a measure of cardiac filling pressure. PAWP will be determined by a right heart catheterization at rest.
Measured: Baseline, 6 months
Change in Pulmonary Arterial Pressure at rest
Pulmonary Arterial Pressure is the measure of pressure that the heart uses to pump blood from the heart to the lungs. Pulmonary Arterial Pressure will be determined by a right heart catheterization at rest and measured in mmHg.
Measured: Baseline, 6 months
Change in Pulmonary Arterial Pressure at exercise
Pulmonary Arterial Pressure is the measure of pressure that the heart uses to pump blood from the heart to the lungs. Pulmonary Arterial Pressure will be determined by a right heart catheterization at exercise and measured in mmHg.
Measured: Baseline, 6 months
Cardiac output
Cardiac output (L/min) is the total volume of blood moved by the heart per minute. Cardiac output is measured during right heart catheterization at exercise using the Fick method.
Measured: Baseline, 6 months
Change in Right Atrial Pressure
Right Atrial Pressure is the blood pressure in the right atrium.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start16 Oct 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Shockwave Medical, Inc.
- Responsible party
- Principal investigator, Claire E. Raphael, Mayo Clinic
- Investigators
- Claire Raphael, M.B.B.S., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057323
- Sponsor's protocol ID
- 25-002292
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure With A Preserved Ejection Fraction Associated With Coronary Microvascular Dysfunction
- ClinicalTrials.gov ID
- NCT07057323
- Acronym / sponsor ID
- 25-002292
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Shockwave Medical, Inc.
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure with a preserved ejection fraction (HFpEF) | Experimental | Device: Coronary Sinus ReducerSubjects with diagnosed Heart failure with a preserved ejection fraction (HFpEF), non-obstructive Coronary Artery Disease (CAD), and have documented CMD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Sinus ReducerSubjects will have the Coronary Sinus Reducer implanted in their coronary sinus during a right heart catheterization procedure. | Device | Heart failure with a preserved ejection fraction (HFpEF) |
Primary outcome
Change in Pulmonary Arterial Wedge Pressure (PAWP) at exercise
Time frame: Baseline, 6 months
Pulmonary Arterial Wedge Pressure (mmHg) is a measure of cardiac filling pressure. PAWP will be determined by a right heart catheterization at 20W exercise.
13 secondary outcomes
Change in Kansas City Cardiomyopathy (KCCQ-12)
Time frame: Baseline, 30 Days, 60 Days, 90 Days, 6 months
Change in Seattle Angina Questionnaire (SAQ)
Time frame: Baseline, 30 Days, 60 Days, 90 Days, 6 months
Change in New York Heart Association (NYHA) classification
Time frame: Baseline, 6 months
Change in Canadian Cardiovascular Society (CCS)
Time frame: Baseline, 30 Days, 60 Days, 90 Days, 6 months
Change in Borg maximal perceived exertion scores
Time frame: Baseline, 6 months
Change in maximum exercise capacity (VO2 max) during supine exercise testing
Time frame: Baseline, 6 months
Change in transcardiac lactate release
Time frame: Baseline, 6 months
Change in transcardiac lactate uptake
Time frame: Baseline, 6 months
Change in Pulmonary Arterial Wedge Pressure (PAWP) at rest
Time frame: Baseline, 6 months
Change in Pulmonary Arterial Pressure at rest
Time frame: Baseline, 6 months
Change in Pulmonary Arterial Pressure at exercise
Time frame: Baseline, 6 months
Cardiac output
Time frame: Baseline, 6 months
Change in Right Atrial Pressure
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Heart Failure Preserved Ejection Fraction
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
Recruiting
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
Heart Failure With Preserved Ejection Fraction
RecruitingPhase 1
A Study of LY3971297 in Participants With Heart Failure
Heart Failure, Heart Failure, Diastolic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claire Raphael, M.B.B.S. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Sinus Reducer in people with Heart Failure Preserved Ejection Fraction, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pulmonary Arterial Wedge Pressure (PAWP) at exercise (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.