Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07057323
Status
Enrolling By Invitation

Conditions

  • Heart Failure Preserved Ejection Fraction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 16, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Change in Pulmonary Arterial Wedge Pressure (PAWP) at exercise [ Time Frame: Baseline, 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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By research site
Mayo Clinic in Rochester· Rochester, MN

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