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Alleviant ALLAY-HFrEF Study

Alleviant Medical, Inc. · NCT06812533

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
350
US sites recruiting
39
Study start
March 10, 2025
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Alleviant ALV1 System; Sham-Control

Conditions: Heart Failure

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Keck Medical Center of USC

    Los Angeles, CA 90033

    Site contact: Michael Fong, MD

  • University California Los Angeles Medical Center

    Los Angeles, CA 90095

    Site contact: Richard Cheng, MD

  • UC Davis Medical Center

    Sacramento, CA 95817

    Site contact: Tai Pham, MD

  • Scripps Clinical Research Services

    San Diego, CA 92121

    Site contact: Rajeev Mohan, MD

  • University of California San Francisco

    San Francisco, CA 94143

    Site contact: Liviu Klein, MD

  • Delray Medical Center

    Delray Beach, FL 33484

    Site contact: Philip Habib, MD

  • Ascension Sacred Heart

    Pensacola, FL 32504

    Site contact: Rohit Amin, MD

  • Tampa General Hospital

    Tampa, FL 33606

    Site contact: Jason Feliberti, MD

  • Atlanta VA Health Care System

    Decatur, GA 30032

    Site contact: Gautum Kumar, MD

  • Midwest Cardiovascular Institute

    Naperville, IL 60540

    Site contact: Stanislaw Skaluba, MD

  • Cardiovascular Institute of the South

    Houma, LA 70360

    Site contact: Peter Fail, MD

  • University Medical Center New Orleans

    New Orleans, LA 70112

    Site contact: Frank Smart, MD

  • Tufts Medical Center

    Boston, MA 02111

    Site contact: Jeong Hwan Kim, MD

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Pinak Shah, MD

  • Boston Medical Center

    Boston, MA 02118

    Site contact: Nir Ayalon, MD

  • Minneapolis Heart Institute Foundation

    Minneapolis, MN 55407

    Site contact: Peter Eckman, MD

  • Washington University - St Louis

    St Louis, MO 63110

    Site contact: Ali Javaheri, MD, PhD

  • UMC of Southern Nevada

    Las Vegas, NV 89102

    Site contact: Ahsan Chowdhury

  • Deborah Heart & Lung Center

    Browns Mills, NJ 08015

    Site contact: Geurys Rojas-Marte

  • Englewood Medical Center

    Englewood, NJ 07631

    Site contact: Ramin Hastings

  • Stony Brook Medicine

    New York, NY 11794

    Site contact: Ahmad Alkhalil, MD

  • Rochester General Hospital

    Rochester, NY 14621

    Site contact: Elizabeth Lee, MD

  • University of Rochester Medical Center

    Rochester, NY 14642

    Site contact: Denizhan Ozdemir, MD, PhD

  • Mission Hospital

    Asheville, NC 28801

    Site contact: Vinay Thohan, MD

  • Duke University Hospital

    Durham, NC 27705

    Site contact: Robert Mentz, MD, FACC, FAHA, HFSA

  • NC Heart and Vascular Research

    Raleigh, NC 27607

    Site contact: Elizabeth Volz, MD

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: J. Emanuel Finet, MD

  • ProMedica Toledo Hospital

    Toledo, OH 43606

    Site contact: P. Kasi Ramanathan, MD

  • Pinnacle Health Cardiovascular Institute

    Harrisburg, PA 17101

    Site contact: Hemal Gada, MD

  • Roper St. Francis Healthcare

    Charleston, SC 29414

    Site contact: Matthew O'Steen, MD

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Brian Houston, MD

  • Monument Health

    Rapid City, SD 57701

    Site contact: Luis Hernandez, MD

  • Tennova Healthcare - Turkey Creek Medical Center

    Knoxville, TN 37934

    Site contact: Malcolm Foster

  • Hendrick Health

    Abilene, TX 79601

    Site contact: Mark Lawrence, D.O.

  • Austin Heart

    Austin, TX 78756

    Site contact: Kunjan Bhatt, MD

  • Baylor Scott & White Research Institute

    Plano, TX 75093

    Site contact: Molly Szerlip

  • Baylor Scott & White - Temple

    Temple, TX 76508

    Site contact: Ernesto Ruiz Duque, MD

  • Waco Cardiology

    Waco, TX 76712

    Site contact: Donald Cross, MD

  • Carilion Clinic

    Roanoke, VA 24014

    Site contact: Daniel Pauly, MD

Study contacts (from the official record)

  • Stacia Kraus · 612-387-4552 · stacia.kraus@alleviantmedical.com
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Alleviant ALLAY-HFrEF Study (NCT06812533) | Bored Studies