Open Actively Recruiting

Alleviant ALLAY-HFrEF Study

About

Brief Summary

Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFrEF.

Primary Purpose
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Treatment
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Interventional
Phase
Phase 3/Phase 4

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • LVEF ≤ 40%
  • NYHA class II, III or ambulatory IV HF
  • Receiving optimal, maximally tolerated, stable GDMT

Exclusion Criteria:

  • Advanced heart failure
  • Life-expectancy < 12 months
  • Evidence of right heart dysfunction

Join this Trial

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Study Stats
Protocol No.
25-2265
Category
Heart/Cardiovascular Diseases
Principal Investigator
Richard Cheng, MD
Richard Cheng, MD
Interventional Cardiology
Contact
  • Ladda Douangvila-Chhan
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT06812533
For detailed technical eligibility, visit ClinicalTrials.gov.