Heart Failure Clinical Trial

Clinical Trial Finder Heart Failure Trials

Alleviant ALLAY-HF Study

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Summary

Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.

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Eligibility Criteria

Inclusion Criteria:

Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
NYHA Class II, III or ambulatory IV

Exercise right heart catheterization*

Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
Exercise PVR < 1.8 WU
Ongoing stable GDMT

Exclusion Criteria:

Advanced heart failure
Presence of a pacemaker
Evidence of right heart dysfunction

Study is for people with:

Heart Failure

Estimated Enrollment:

500

Study ID:

NCT05685303

Recruitment Status:

Enrolling by invitation

Sponsor:

Alleviant Medical, Inc.

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There are 4 Locations for this study

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Prairie Education and Research Cooperative
Springfield Illinois, 62769, United States
Cardiovascular Institute of the South
Houma Louisiana, 70360, United States
Monument Health
Rapid City South Dakota, 57701, United States
Hendrick Health
Abilene Texas, 79601, United States
Tbilisi Heart and Vascular
Tbilisi , , Georgia

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

500

Study ID:

NCT05685303

Recruitment Status:

Enrolling by invitation

Sponsor:


Alleviant Medical, Inc.

How clear is this clinincal trial information?

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