Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure

NCT07057323 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 25-002292
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 months

Secondary Outcomes (13)

• Change in Kansas City Cardiomyopathy (KCCQ-12)

  Baseline, 30 Days, 60 Days, 90 Days, 6 months

• Change in Seattle Angina Questionnaire (SAQ)

  Baseline, 30 Days, 60 Days, 90 Days, 6 months

• Change in New York Heart Association (NYHA) classification

  Baseline, 6 months

• Change in Canadian Cardiovascular Society (CCS)

  Baseline, 30 Days, 60 Days, 90 Days, 6 months

• Change in Borg maximal perceived exertion scores

  Baseline, 6 months

Study Arms (1)

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.

Device: Coronary Sinus Reducer

Interventions

Coronary Sinus Reducer DEVICE

Subjects will have the Coronary Sinus Reducer implanted in their coronary sinus during a right heart catheterization procedure.

Heart failure with a preserved ejection fraction (HFpEF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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 planned implantation greater than 13mm or less than 9.5 mm as measured by angiogram.
• Known severe reaction to required procedural medications

Sponsors & Collaborators

• Mayo Clinic: lead
• Shockwave Medical, Inc.: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Claire Raphael, M.B.B.S.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 9, 2025
• Study Start: October 16, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)