Alleviant ALLAY-HF Study
Alleviant Medical, Inc. · NCT05685303
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
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