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Alleviant ALLAY-HF Study

Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe and effective the Alleviant ALV1 System is at making a small opening between the heart’s upper chambers. It is for people with heart failure who have symptoms and whose heart pumps out at least 40% of its blood with each beat. The study compares the treatment with a sham procedure, which does not make the opening.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have heart failure with symptoms and a heart pumping measure called LVEF of at least 40%.
  • Have symptoms that limit activity (NYHA class II or III), or symptoms at rest but still be able to walk (ambulatory class IV).
  • Have pressure of at least 25 mmHg in the heart’s upper left chamber during exercise, measured with a thin tube placed in the heart.
  • Have resistance to blood flow through the lungs below 1.8 Wood units during the exercise test.
  • Be on a stable treatment plan recommended by heart failure care guidelines.

Who can't join

  • Have advanced heart failure.
  • Have a pacemaker.
  • Have signs that the right side of the heart is not working well.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (56)

AZ

CA

CT

FL

GA

  • Atlanta VA Health Care System · Decatur, GA 30032Gautum Kumar, MD · Principal investigatorMore trials in Decatur

IL

IN

KY

  • St. Elizabeth Healthcare · Edgewood, KY 41017Benjamin Peterson, MD · Principal investigatorMore trials in Edgewood

LA

  • Cardiovascular Institute of the South · Houma, LA 70360Peter Fail, MD · Principal investigatorMore trials in Houma
  • University Medical Center New Orleans · New Orleans, LA 70112Frank Smart, MD · Principal investigatorMore trials in New Orleans

MA

MD

  • Johns Hopkins Medical Institution · Baltimore, MD 21287Kavita Sharma, MD · Principal investigatorMore trials in Baltimore

MI

MN

  • Minneapolis Heart Institute Foundation · Minneapolis, MN 55407Peter Eckman, MD · Principal investigatorMore trials in Minneapolis

MO

  • Washington University - St Louis · St Louis, MO 63110Ali Javaheri, MD, PhD · Principal investigatorMore trials in St Louis

NC

NV

NY

OH

OK

OR

PA

  • Pinnacle Health Cardiovascular Institute · Harrisburg, PA 17101Roberto Hodara, MD · Principal investigatorHemal Gada, MD · Principal investigatorMore trials in Harrisburg

SC

  • Medical University of South Carolina · Charleston, SC 29425Sheldon Litwin, MD · Principal investigatorMore trials in Charleston
  • Prisma Health - Midlands · Colombia, SC 29203Vince Vismara, MD · Principal investigatorMore trials in Colombia

SD

TN

  • Stern Cardiovascular Foundation · Germantown, TN 38138Basil Paulus, MD · Principal investigatorMore trials in Germantown
  • Tennova Healthcare - Turkey Creek Medical Center · Knoxville, TN 37934Malcolm Foster, MD · Principal investigatorMore trials in Knoxville

TX

  • Hendrick Health · Abilene, TX 79601Mark Lawrence, D.O. · Principal investigatorMore trials in Abilene
  • Austin Heart · Austin, TX 78756Kunjan Bhatt, MD · Principal investigatorMore trials in Austin
  • UT Southwestern · Dallas, TX 75930Ambarish Pandey, MD · Principal investigatorMore trials in Dallas
  • Baylor Scott & White Research Institute · Plano, TX 75093Mollyu Szerlip, MD · Principal investigatorMore trials in Plano
  • Waco Cardiology · Waco, TX 76712Donald Cross, MD · Principal investigatorMore trials in Waco

WA

WI