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Alleviant ALLAY-HF Study

RecruitingNAAges 40 Years - anyAllAlleviant Medical, Inc.
NCT05685303 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • Alleviant ALV1 System
  • Sham-Control
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Where

93 sites
Arizona Cardiovascular Research Center
Phoenix, United States
HonorHealth
Scottsdale, United States
Pima Heart and Vascular
Tucson, United States
Memorial Care Long Beach Medical Center
Long Beach, United States
UC Davis Medical Center
Sacramento, United States
Scripps Clinical Research Services
San Diego, United States
University of California San Francisco
San Francisco, United States
Santa Barbara Cottage Hospital
Santa Barbara, United States

…and 85 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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