Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure

NCT ID: NCT07057323

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-16
• Study Completion Date: 2027-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Heart failure with a preserved ejection fraction (HFpEF)

Subjects with diagnosed Heart failure with a preserved ejection fraction (HFpEF), non-obstructive Coronary Artery Disease (CAD), and have documented CMD.

Group Type: EXPERIMENTAL

Coronary Sinus Reducer

Intervention Type: DEVICE

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

Interventions

Coronary Sinus Reducer

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

Intervention Type: DEVICE

Eligibility Criteria

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 6 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:

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shockwave Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Amir Lerman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir Lerman

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

25-002292

Identifier Type: -

Identifier Source: org_study_id