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Alleviant ALLAY-HF Study

RECRUITINGN/ASponsored by Alleviant Medical, Inc.
Actively Recruiting
PhaseN/A
SponsorAlleviant Medical, Inc.
Started2023-01-10
Est. completion2027-12-01
Eligibility
Age40 Years+
Healthy vol.Accepted
Locations56 sites
View on ClinicalTrials.gov →

NCT05685303

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.

Eligibility

Age: 40 Years+Healthy volunteers accepted
Inclusion Criteria:

1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
2. NYHA Class II, III or ambulatory IV
3. Exercise right heart catheterization\*

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

Exclusion Criteria:

1. Advanced heart failure
2. Presence of a pacemaker
3. Evidence of right heart dysfunction

Conditions2

Heart DiseaseHeart Failure

Locations56 sites

Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016
HonorHealth
Scottsdale, Arizona, 85258
Pima Heart and Vascular
Tucson, Arizona, 85718
Thomas Waggoner, DO
Memorial Care Long Beach Medical Center
Long Beach, California, 90806
Kevin Shah, MD
UC Davis Medical Center
Sacramento, California, 95817
Tai Pham, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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