Heart FailureNCT06812533
Alleviant ALLAY-HFrEF Study
A study testing Alleviant ALV1 System in people with Heart Failure, run by Alleviant Medical, Inc. at 70 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Alleviant ALV1 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 70 sitesin 11 countries
- Study dates
- 10 Mar 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LVEF ≤ 40%
- NYHA class II, III or ambulatory IV HF
- Receiving optimal, maximally tolerated, stable GDMT
Who cannot join
- Advanced heart failure
- Life-expectancy < 12 months
- Evidence of right heart dysfunction
Trial locations and contacts
70 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
70 sites in 11 countries
United States40 sites, 39 recruiting
- Recruiting
Hendrick Health
Abilene, Texas, 79601
Mark Lawrence, D.O.
- Recruiting
Mission Hospital
Asheville, North Carolina, 28801
Vinay Thohan, MD
- Terminated
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
- Recruiting
Austin Heart
Austin, Texas, 78756
Kunjan Bhatt, MD
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Jeong Hwan Kim, MD
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Pinak Shah, MD
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Nir Ayalon, MD
- Recruiting
Deborah Heart & Lung Center
Browns Mills, New Jersey, 08015
Geurys Rojas-Marte
- Recruiting
Roper St. Francis Healthcare
Charleston, South Carolina, 29414
Matthew O'Steen, MD
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Brian Houston, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
J. Emanuel Finet, MD
- Recruiting
Atlanta VA Health Care System
Decatur, Georgia, 30032
Gautum Kumar, MD
- Recruiting
Delray Medical Center
Delray Beach, Florida, 33484
Philip Habib, MD
- Recruiting
Duke University Hospital
Durham, North Carolina, 27705
Robert Mentz, MD, FACC, FAHA, HFSA
- Recruiting
Englewood Medical Center
Englewood, New Jersey, 07631
Ramin Hastings
- Recruiting
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, 17101
Hemal Gada, MD
- Recruiting
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Peter Fail, MD
- Recruiting
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, 37934
Malcolm Foster
- Recruiting
UMC of Southern Nevada
Las Vegas, Nevada, 89102
Ahsan Chowdhury
- Recruiting
Keck Medical Center of USC
Los Angeles, California, 90033
Michael Fong, MD
- Recruiting
University California Los Angeles Medical Center
Los Angeles, California, 90095
Richard Cheng, MD
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Peter Eckman, MD
- Recruiting
Midwest Cardiovascular Institute
Naperville, Illinois, 60540
Stanislaw Skaluba, MD
- Recruiting
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Frank Smart, MD
- Recruiting
Stony Brook Medicine
New York, New York, 11794
Ahmad Alkhalil, MD
- Recruiting
Ascension Sacred Heart
Pensacola, Florida, 32504
Rohit Amin, MD
- Recruiting
Baylor Scott & White Research Institute
Plano, Texas, 75093
Molly Szerlip
- Recruiting
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
Elizabeth Volz, MD
- Recruiting
Monument Health
Rapid City, South Dakota, 57701
Luis Hernandez, MD
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24014
Daniel Pauly, MD
- Recruiting
Rochester General Hospital
Rochester, New York, 14621
Elizabeth Lee, MD
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Denizhan Ozdemir, MD, PhD
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
Tai Pham, MD
- Recruiting
Scripps Clinical Research Services
San Diego, California, 92121
Rajeev Mohan, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Liviu Klein, MD
- Recruiting
Washington University - St Louis
St Louis, Missouri, 63110
Ali Javaheri, MD, PhD
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Jason Feliberti, MD
- Recruiting
Baylor Scott & White - Temple
Temple, Texas, 76508
Ernesto Ruiz Duque, MD
- Recruiting
ProMedica Toledo Hospital
Toledo, Ohio, 43606
P. Kasi Ramanathan, MD
- Recruiting
Waco Cardiology
Waco, Texas, 76712
Donald Cross, MD
Spain8 sites, 7 recruiting
- Recruiting
Hospital Universitario A Coruna
A Coruña
Maria Generosa Crespo Leiro, Prof.
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Sonia Mirabet, MD, PhD
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
Omar Abdul-Jawad Altisent
- Recruiting
Vall d'Hebron University Hospital Barcelona
Barcelona
Eduardo Rodenas-Alesina
- Terminated
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Universitario Puerta de Hierro
Madrid, 28222
Marta Cobo Marcos, Prof.
- Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca
David González Calle, MD
- Recruiting
Valencia Hospital Clinico
Valencia, 46010
Julio Nunez
Canada4 sites, 4 recruiting
- Recruiting
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0C1
Brian Potter, MD
- Recruiting
Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
Montreal, Quebec, H2X 0C1
Benoit Daneault, MD
- Recruiting
Southlake Regional Hospital Centre
Newmarket, Ontario, L3Y 2P6
Liane Porepa, MD
- Recruiting
IUCPQ - Université Laval (Quebec)
Québec, Quebec, G1V 4G5
Josep Rodés-Cabau, MD, PhD
Belgium3 sites, 3 recruiting
- Recruiting
OLV Hospital
Aalst
Jozef Bartunek, Prof.
- Recruiting
ZAS Middelheim
Antwerp
Stefan Verheye
- Recruiting
AZ Sint Jan Brugge
Bruges
Jan Van der Heyden, Prof.
Greece3 sites, 3 recruiting
- Recruiting
Hippocration General Hospital Athens
Athens, 11527
Konstantinos Toutouzas
- Recruiting
Hygeia Hospital
Athens, 15123
Elias Tsougos
- Recruiting
European Interbalken Medical Center
Thessaloniki
Vlasis Ninios
Poland3 sites, 3 recruiting
- Recruiting
University Clinical Hospital in Opole
Opole
Jerzy Sacha
- Recruiting
Narodowy Instytut Kardiologii im. Stefana kardynała Wyszyńsk
Warsaw
Przemysław Leszek
- Recruiting
Uniwesytecki Szpital Kliniczny
Wroclaw
Jan Biegus, Prof.
Australia2 sites, 2 recruiting
- Recruiting
Monash Health Victorian Heart Hospital
Clayton, Victoria, 3068
Robert Gooley
- Recruiting
Alfred Hospital
Melbourne, Victoria, 3004
David Kaye
Israel2 sites, 2 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv
Michael Laufer-Perl
- Recruiting
Shamir Medical Center
Zrifin
Gil Moravsky
New Zealand2 sites, 2 recruiting
- Recruiting
ChristChurch Hospital
Christchurch, 8011
Richard Troughton
- Recruiting
Dunedin Hospital
Dunedin, 9016
Gerard Wilkins
Serbia2 sites, 2 recruiting
- Recruiting
National Institute for Heart and Blood Vessels Dedinje
Belgrade, 11040
Stefan Simović
- Recruiting
University Clinical Centre of Kragujevac
Kragujevac, 34000
Stefan Simović
Georgia1 site, 1 recruiting
- Recruiting
Tbilisi Heart and Vascular
Tbilisi
Tamaz Shaburishvili
About this study
Official title: Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction
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.
- Conditions
- Heart Failure
- Being tested
- Alleviant ALV1 System, Sham-Control
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alleviant ALV1 SystemDevice
Creation of interatrial shunt
Sham-ControlOther
Cardiac imaging
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure. Receives: Device: Alleviant ALV1 System |
| Control | Sham comparator | Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein. Receives: Other: Sham-Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Primary Endpoint
The primary endpoint is a composite of all-cause mortality or cardiac transplantation or permanent left ventricular assist device (LVAD) and heart failure events.
Measured: 12-Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start10 Mar 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alleviant Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregg Stone, Principal investigator, Icahn School of Medicine at Mount SinaiJames Udelson, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812533
- Sponsor's protocol ID
- CIP-0006
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT06812533
- Acronym / sponsor ID
- CIP-0006
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Alleviant Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Alleviant ALV1 SystemSubjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure. |
| Control | Sham comparator | Other: Sham-ControlSubjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- LVEF ≤ 40%
- NYHA class II, III or ambulatory IV HF
- Receiving optimal, maximally tolerated, stable GDMT
Key exclusion criteria (3 listed)
- Advanced heart failure
- Life-expectancy < 12 months
- Evidence of right heart dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alleviant ALV1 SystemCreation of interatrial shunt | Device | Treatment |
| Sham-ControlCardiac imaging | Other | Control |
Primary outcome
Composite Primary Endpoint
Time frame: 12-Month
The primary endpoint is a composite of all-cause mortality or cardiac transplantation or permanent left ventricular assist device (LVAD) and heart failure events.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregg Stone principal investigator
Icahn School of Medicine at Mount Sinai
James Udelson principal investigator
Tufts Medical Center
70 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alleviant ALV1 System in people with Heart Failure, run by Alleviant Medical, Inc. at 70 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, Spain, Canada, Belgium, Greece and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacia Kraus (612-387-4552, stacia.kraus@alleviantmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Primary Endpoint (time frame: 12-Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.