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Alleviant ALLAY-HF Study
Alleviant ALLAY-HF Study

NCT05685303

RecruitingNA

Sponsor: Alleviant Medical, Inc.

Conditions: Heart Failure

Interventions: Alleviant ALV1 System, Sham-Control

Countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Georgia

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 overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (93)
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Tucson, Arizona, United States
  • Long Beach, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • San Francisco, California, United States
  • Santa Barbara, California, United States
  • Hartford, Connecticut, United States
  • Gainesville, Florida, United States
  • Jacksonville, Florida, United States
  • Naples, Florida, United States
  • Orlando, Florida, United States
  • Pensacola, Florida, United States
  • Decatur, Georgia, United States
  • Chicago, Illinois, United States
  • Naperville, Illinois, United States
  • Springfield, Illinois, United States
  • Indianapolis, Indiana, United States
  • Edgewood, Kentucky, United States
  • Houma, Louisiana, United States
  • New Orleans, Louisiana, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Brighton, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Detroit, Michigan, United States
  • Minneapolis, Minnesota, United States
  • St Louis, Missouri, United States
  • + 63 more on CT.gov