Recruiting

Alleviant ALV1Alleviant ALLAY-HF Study

Sponsor:

Alleviant Medical, Inc.

Code:

NCT05685303

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Alleviant ALV1 System

Sham-Control

Study Details

Brief summary:

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.

Conditions

Heart Failure

Study ID

NCT05685303

Start date

Jan 10, 2023

Status verified date

Aug, 2026

Completion date

Dec 1, 2032

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.

sham comparator: Control

Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.

Interventions

Alleviant ALV1 System

Creation of interatrial shunt

Sham-Control

Cardiac imaging

Primary outcome measure

Composite Primary Endpoint [ Time Frame: 12-month ]

Central Contacts and Locations

Central contacts

Jennifer Olson

+1 612 327 2741 jen.olson@alleviantmedical.com

Locations

Pima Heart and Vascular

Recruiting

Tucson, Arizona, United States, 85718

Principal Investigator:

Thomas Waggoner, DO

Memorial Care Long Beach Medical Center

Recruiting

Long Beach, California, United States, 90806

Principal Investigator:

Kevin Shah, MD

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Principal Investigator:

Tai Pham, MD

Scripps Clinical Research Services

Recruiting

San Diego, California, United States, 92121

Principal Investigator:

Rajeev Mohan, MD

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Principal Investigator:

Richard Cheng, MD

Santa Barbara Cottage Hospital

Recruiting

Santa Barbara, California, United States, 93105

Principal Investigator:

Joseph Aragon, MD

The Cardiac and Vascular Institute (TCAVI)

Recruiting

Gainesville, Florida, United States, 32504

Principal Investigator:

Ann Tong, MD

HCA Florida Memorial Hospital

Recruiting

Jacksonville, Florida, United States, 32216

Principal Investigator:

Amir Azarbal, MD

NCH Research Institute

Recruiting

Naples, Florida, United States, 34102

Principal Investigator:

Mazen Albaghdadi, MD

Advent Health Orlando

Recruiting

Orlando, Florida, United States, 32803

Principal Investigator:

Rohit Bhatheja, MD

Ascension Sacred Heart

Recruiting

Pensacola, Florida, United States, 32504

Principal Investigator:

Rohit Amin, MD

Atlanta VA Health Care System

Recruiting

Decatur, Georgia, United States, 30032

Principal Investigator:

Gautum Kumar, MD

Midwest Cardiovascular Institute

Recruiting

Naperville, Illinois, United States, 60540

Principal Investigator:

Maria Rosa Costanzo, MD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Sujal Modi, MD

St. Elizabeth Healthcare

Recruiting

Edgewood, Kentucky, United States, 41017

Principal Investigator:

Benjamin Peterson, MD

Cardiovascular Institute of the South

Recruiting

Houma, Louisiana, United States, 70360

Principal Investigator:

Peter Fail, MD

University Medical Center New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Principal Investigator:

Frank Smart, MD

Johns Hopkins Medical Institution

Recruiting

Baltimore, Maryland, United States, 21287

Principal Investigator:

Kavita Sharma, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Pinak Shah, MD

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Principal Investigator:

Deepa Gopal, MD

VA Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48105

Principal Investigator:

Scott Hummel, MD, MS

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Principal Investigator:

Peter Eckman, MD

Washington University - St Louis

Recruiting

St Louis, Missouri, United States, 63110

Principal Investigator:

Ali Javaheri, MD, PhD

UMC of Southern Nevada

Recruiting

Las Vegas, Nevada, United States, 89102

Principal Investigator:

Ahsan Chowdhury

New York University

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Tajinderpal Saraon, MD

Stony Brook Medicine

Recruiting

Stony Brook, New York, United States, 11794-8167

Principal Investigator:

Ahmad Alkhalil, MD

Mission Hospital

Recruiting

Asheville, North Carolina, United States, 28801

Principal Investigator:

Vinay Thohan, MD

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27705

Principal Investigator:

Kishan Parikh, MD

NC Heart and Vascular Research

Recruiting

Raleigh, North Carolina, United States, 27607

Principal Investigator:

Elizabeth Volz, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Rishi Puri, MD

ProMedica Toledo Hospital

Recruiting

Toledo, Ohio, United States, 43606

Principal Investigator:

Kasi Ramanathan, MD

South Oklahoma Heart Research, LLC.

Recruiting

Oklahoma City, Oklahoma, United States, 73135

Principal Investigator:

Naeem Tahirkheli, MD

Pinnacle Health Cardiovascular Institute

Recruiting

Harrisburg, Pennsylvania, United States, 17101

Principal Investigator:

Roberto Hodara, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator:

Sheldon Litwin, MD

Prisma Health - Midlands

Recruiting

Colombia, South Carolina, United States, 29203

Principal Investigator:

Vince Vismara, MD

Monument Health

Recruiting

Rapid City, South Dakota, United States, 57701

Principal Investigator:

K John Heilman III, MD

Stern Cardiovascular Foundation

Recruiting

Germantown, Tennessee, United States, 38138

Principal Investigator:

Basil Paulus, MD

Tennova Healthcare - Turkey Creek Medical Center

Recruiting

Knoxville, Tennessee, United States, 37934

Principal Investigator:

Malcolm Foster, MD

Hendrick Health

Recruiting

Abilene, Texas, United States, 79601

Principal Investigator:

Mark Lawrence, D.O.

Austin Heart

Recruiting

Austin, Texas, United States, 78756

Principal Investigator:

Kunjan Bhatt, MD

UT Southwestern

Recruiting

Dallas, Texas, United States, 75930

Principal Investigator:

Ambarish Pandey, MD

Baylor Scott & White Research Institute

Recruiting

Plano, Texas, United States, 75093

Principal Investigator:

Mollyu Szerlip, MD

Waco Cardiology

Recruiting

Waco, Texas, United States, 76712

Principal Investigator:

Donald Cross, MD

Southlake Regional Hospital Centre

Recruiting

Newmarket, Ontario, Canada, L3Y 2P6

Principal Investigator:

Liane Porepa, MD

Centre hospitalier de l'Universite de Montreal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Principal Investigator:

Brian Potter, MD

Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Principal Investigator:

Benoit Daneault, MD

More Information

Sponsor

Alleviant Medical, Inc.

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alleviant Medical, Inc. on 2026-08-14.