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Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure

NCT07057323 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-03-20

No results posted yet for this study

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

Interventions

DEVICE

Coronary Sinus Reducer

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

Sponsors & Collaborators

  • Shockwave Medical, Inc.

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Claire Raphael, M.B.B.S. · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-16
Primary Completion
2027-08-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07057323 on ClinicalTrials.gov