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Recruiting

Alleviant ALLAY-HF Study

Alleviant Medical, Inc. · NCT05685303

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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 40+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
700
US sites recruiting
43
Study start
January 10, 2023
Record last updated
August 14, 2026

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

What the study is about

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.

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

  • Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
  • NYHA Class II, III or ambulatory IV
  • Exercise right heart catheterization*
  • Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
  • Exercise PVR \< 1.8 WU
  • Ongoing stable GDMT

Exclusion Criteria

  • Advanced heart failure
  • Presence of a pacemaker
  • Evidence of right heart dysfunction

Recruiting US locations

  • Pima Heart and Vascular

    Tucson, AZ 85718

    Site contact: Thomas Waggoner, DO

  • Memorial Care Long Beach Medical Center

    Long Beach, CA 90806

    Site contact: Kevin Shah, 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: Richard Cheng, MD

  • Santa Barbara Cottage Hospital

    Santa Barbara, CA 93105

    Site contact: Joseph Aragon, MD

  • The Cardiac and Vascular Institute (TCAVI)

    Gainesville, FL 32504

    Site contact: Ann Tong, MD

  • HCA Florida Memorial Hospital

    Jacksonville, FL 32216

    Site contact: Amir Azarbal, MD

  • NCH Research Institute

    Naples, FL 34102

    Site contact: Mazen Albaghdadi, MD

  • Advent Health Orlando

    Orlando, FL 32803

    Site contact: Rohit Bhatheja, MD

  • Ascension Sacred Heart

    Pensacola, FL 32504

    Site contact: Rohit Amin, MD

  • Atlanta VA Health Care System

    Decatur, GA 30032

    Site contact: Gautum Kumar, MD

  • Midwest Cardiovascular Institute

    Naperville, IL 60540

    Site contact: Maria Rosa Costanzo, MD

  • Indiana University

    Indianapolis, IN 46202

    Site contact: Sujal Modi, MD

  • St. Elizabeth Healthcare

    Edgewood, KY 41017

    Site contact: Benjamin Peterson, 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

  • Johns Hopkins Medical Institution

    Baltimore, MD 21287

    Site contact: Kavita Sharma, MD

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Pinak Shah, MD

  • Boston Medical Center

    Boston, MA 02118

    Site contact: Deepa Gopal, MD

  • VA Ann Arbor

    Ann Arbor, MI 48105

    Site contact: Scott Hummel, MD, MS

  • 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

  • New York University

    New York, NY 10016

    Site contact: Tajinderpal Saraon, MD

  • Stony Brook Medicine

    Stony Brook, NY 11794-8167

    Site contact: Ahmad Alkhalil, MD

  • Mission Hospital

    Asheville, NC 28801

    Site contact: Vinay Thohan, MD

  • Duke University Hospital

    Durham, NC 27705

    Site contact: Kishan Parikh, MD

  • NC Heart and Vascular Research

    Raleigh, NC 27607

    Site contact: Elizabeth Volz, MD

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Rishi Puri, MD

  • ProMedica Toledo Hospital

    Toledo, OH 43606

    Site contact: Kasi Ramanathan, MD

  • South Oklahoma Heart Research, LLC.

    Oklahoma City, OK 73135

    Site contact: Naeem Tahirkheli, MD

  • Pinnacle Health Cardiovascular Institute

    Harrisburg, PA 17101

    Site contact: Roberto Hodara, MD

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Sheldon Litwin, MD

  • Prisma Health - Midlands

    Colombia, SC 29203

    Site contact: Vince Vismara, MD

  • Monument Health

    Rapid City, SD 57701

    Site contact: K John Heilman III, MD

  • Stern Cardiovascular Foundation

    Germantown, TN 38138

    Site contact: Basil Paulus, MD

  • Tennova Healthcare - Turkey Creek Medical Center

    Knoxville, TN 37934

    Site contact: Malcolm Foster, MD

  • Hendrick Health

    Abilene, TX 79601

    Site contact: Mark Lawrence, D.O.

  • Austin Heart

    Austin, TX 78756

    Site contact: Kunjan Bhatt, MD

  • UT Southwestern

    Dallas, TX 75930

    Site contact: Ambarish Pandey, MD

  • Baylor Scott & White Research Institute

    Plano, TX 75093

    Site contact: Mollyu Szerlip, MD

  • Waco Cardiology

    Waco, TX 76712

    Site contact: Donald Cross, MD

Study contacts (from the official record)

  • Jennifer Olson · +1 612 327 2741 · jen.olson@alleviantmedical.com
Alleviant ALLAY-HF Study (NCT05685303) | Bored Studies