Heart FailureNCT05685303
Alleviant ALLAY-HF Study
A study testing Alleviant ALV1 System in people with Heart Failure, run by Alleviant Medical, Inc. at 93 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 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
- 700 participants
- Where
- 93 sitesin 14 countries
- Study dates
- 10 Jan 2023to 1 Dec 2032
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Advanced heart failure
- Presence of a pacemaker
- Evidence of right heart dysfunction
Trial locations and contacts
93 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
93 sites in 14 countries
United States56 sites, 43 recruiting
- Recruiting
Hendrick Health
Abilene, Texas, 79601
Mark Lawrence, D.O.
- Recruiting
VA Ann Arbor
Ann Arbor, Michigan, 48105
Scott Hummel, MD, MS
- Recruiting
Mission Hospital
Asheville, North Carolina, 28801
Vinay Thohan, MD
- Recruiting
Austin Heart
Austin, Texas, 78756
Kunjan Bhatt, MD
- Recruiting
Johns Hopkins Medical Institution
Baltimore, Maryland, 21287
Kavita Sharma, MD
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Pinak Shah, MD
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Deepa Gopal, MD
- Terminated
Steward St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Sheldon Litwin, MD
- Terminated
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Rishi Puri, MD
- Recruiting
Prisma Health - Midlands
Colombia, South Carolina, 29203
Vince Vismara, MD
- Recruiting
UT Southwestern
Dallas, Texas, 75930
Ambarish Pandey, MD
- Recruiting
Atlanta VA Health Care System
Decatur, Georgia, 30032
Gautum Kumar, MD
- Terminated
Ascension St. John Hospital
Detroit, Michigan, 48236
- Recruiting
Duke University Hospital
Durham, North Carolina, 27705
Kishan Parikh, MD
- Recruiting
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
Benjamin Peterson, MD
- Recruiting
The Cardiac and Vascular Institute (TCAVI)
Gainesville, Florida, 32504
Ann Tong, MD
- Recruiting
Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
Basil Paulus, MD
- Recruiting
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, 17101
Roberto Hodara, MD
Hemal Gada, MD
- Terminated
Hartford Hospital
Hartford, Connecticut, 06106
- Recruiting
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Peter Fail, MD
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Sujal Modi, MD
- Recruiting
HCA Florida Memorial Hospital
Jacksonville, Florida, 32216
Amir Azarbal, MD
- Recruiting
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, 37934
Malcolm Foster, MD
- Recruiting
UMC of Southern Nevada
Las Vegas, Nevada, 89102
Ahsan Chowdhury
- Recruiting
Memorial Care Long Beach Medical Center
Long Beach, California, 90806
Kevin Shah, MD
- Active, not recruiting
Advocate Aurora Health/Aurora Research Institute
Milwaukee, Wisconsin, 53215
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Peter Eckman, MD
- Recruiting
Midwest Cardiovascular Institute
Naperville, Illinois, 60540
Maria Rosa Costanzo, MD
- Recruiting
NCH Research Institute
Naples, Florida, 34102
Mazen Albaghdadi, MD
- Recruiting
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Frank Smart, MD
- Terminated
VA NY Harbor Healthcare System
New York, New York, 10010
- Recruiting
New York University
New York, New York, 10016
Tajinderpal Saraon, MD
- Active, not recruiting
Lenox Hill Hospital
New York, New York, 10075
- Recruiting
South Oklahoma Heart Research, LLC.
Oklahoma City, Oklahoma, 73135
Naeem Tahirkheli, MD
- Recruiting
Advent Health Orlando
Orlando, Florida, 32803
Rohit Bhatheja, MD
- Recruiting
Ascension Sacred Heart
Pensacola, Florida, 32504
Rohit Amin, MD
- Active, not recruiting
Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016
- Recruiting
Baylor Scott & White Research Institute
Plano, Texas, 75093
Mollyu Szerlip, MD
- Terminated
Providence St. Vincent's Medical Center
Portland, Oregon, 97225
- Recruiting
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
Elizabeth Volz, MD
- Recruiting
Monument Health
Rapid City, South Dakota, 57701
K John Heilman III, MD
- Terminated
St. Francis Hospital
Roslyn, New York, 11576
- 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
Richard Cheng, MD
- Recruiting
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
Joseph Aragon, MD
- Terminated
HonorHealth
Scottsdale, Arizona, 85258
- Active, not recruiting
University of Washington
Seattle, Washington, 98195
- Active, not recruiting
Prairie Education and Research Cooperative
Springfield, Illinois, 62769
- Recruiting
Washington University - St Louis
St Louis, Missouri, 63110
Ali Javaheri, MD, PhD
- Recruiting
Stony Brook Medicine
Stony Brook, New York, 11794-8167
Ahmad Alkhalil, MD
- Recruiting
ProMedica Toledo Hospital
Toledo, Ohio, 43606
Kasi Ramanathan, MD
- Recruiting
Pima Heart and Vascular
Tucson, Arizona, 85718
Thomas Waggoner, DO
- Recruiting
Waco Cardiology
Waco, Texas, 76712
Donald Cross, MD
Spain9 sites, 7 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Sonia Mirabel, MD, PhD
- Recruiting
Barcelona Hospital del Mar
Barcelona, 08033
Nuria Farre, MD
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
Omar Abdul-Jawad Altisent, MD, PhD
- Terminated
Germans Trias i Pujol University Hospital
Barcelona, 08916
- Recruiting
Vall d'Hebron University Hospital Barcelona
Barcelona
Eduard Ródenas-Alesina
- Terminated
Hospital Universitario Puerta del Cadíz
Cadiz, 11009
- Recruiting
Hospital Universitario Puerta de Hierro
Madrid, 28222
Marta Cobo Marcos, MD
- Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca
Inès Maria Toranzo Nieto
- Recruiting
Valencia Hospital Clinico
Valencia, 46010
Julio Nunez, MD, PhD
Poland6 sites, 6 recruiting
- Recruiting
University Clinical Hospital in Opole
Opole
Jerzy Sacha
- Recruiting
Poznan University of Medical Sciences
Poznan
Marek Grygier, MD, PhD
- Recruiting
Kashubian Center for Heart and Vascular Diseases, Pomeranian
Wejherowo, 84-200
Lukasz Lewicki
- Recruiting
4th Military Hospital
Wroclaw
Bartek Krakowiak, MD, PhD
- Recruiting
Uniwesytecki Szpital Kliniczny
Wroclaw
Jan Leon Biegus, MD, PhD
- Recruiting
Silesian Center for Heart Disease
Zabrze
Michal Hawranek
Belgium3 sites, 3 recruiting
- Recruiting
OLV Hospital
Aalst
Martin Penicka, MD, PhD
- Recruiting
ZAS Middelheim
Antwerp
Stefan Verheye
- Recruiting
AZ Sint Jan Brugge
Bruges
Jan Van der Heyden, MD, PhD
Canada3 sites, 3 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
Germany3 sites, 2 recruiting
- Terminated
Marienkrankenhaus
Hamburg, 22087
- Recruiting
Universitatsklinikum Schleswig-Holstein (UKSH)
Lübeck, 23538
Tobias Schmidt, MD
- Recruiting
Universitätsklinikum Kardiologie
Magdeburg, 39120
Rüdiger Braun-Dullaeus, MD, PhD
Israel3 sites, 2 recruiting
- Terminated
Shaare Zedek Medical Center
Jerusalem
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv
Michal Laufer-Perl, MD
- Recruiting
Shamir Medical Center
Zrifin
Gil Moravsky, MD
Australia2 sites, 2 recruiting
- Recruiting
Monash Health Victorian Heart Hospital
Clayton, Victoria, 3068
Robert Gooley, A/Prof
- Recruiting
Austin Hospital
Heidelberg, Victoria, 3084
Matias Yudi
Italy2 sites, 1 recruiting
- Recruiting
Instituto Auxologico Italiano
Milan, 20149
Sergio Caravita, MD, PhD
- Terminated
Humanitas Research Milan
Rozzano, Michigan
New Zealand2 sites, 2 recruiting
- Recruiting
ChristChurch Hospital
Christchurch, 8011
Richard Troughton, PhD
- Recruiting
Dunedin Hospital
Dunedin, 9016
Gerry Wilkins, A/Prof
Austria1 site, 1 recruiting
- Recruiting
Medizinische Universität Graz
Graz
Gabor Toth, MD, PhD
Bulgaria1 site, 1 recruiting
- Recruiting
University Hospital UMHAT Sveti Georgi
Plovdiv, 4002
Krasimir Dzhinsov
Czechia1 site, 1 recruiting
- Recruiting
Kardiocentrum Nemocnice AGEL Trinec-Podlesi
Třinec, 73961
Jaroslav Januska
Georgia1 site, 1 recruiting
- Recruiting
Tbilisi Heart and Vascular
Tbilisi
Tamaz Shaburishvili
About this study
Official title: Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
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
- 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 mortality, heart failure events and quality of life based on Kansas City Cardiomyopathy Questionnaire (KCCQ) calculated at 12 months. KCCQ responses are provided along a rating scale from 0-100 with a higher score indicating better health.
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 posted17 Jan 2023
- Study start10 Jan 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2032 (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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alleviant Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Udelson, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685303
- Sponsor's protocol ID
- CIP-0003
- Status last verified
- Aug 2026
- First submitted
- 14 Dec 2022
- Last updated
- 14 Aug 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 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05685303
- Acronym / sponsor ID
- CIP-0003
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Alleviant Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 17 Jan 2023 (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 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.
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
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
- NYHA Class II, III or ambulatory IV
- Exercise right heart catheterization*
- Ongoing stable GDMT
Key exclusion criteria (3 listed)
- Advanced heart failure
- Presence of a pacemaker
- 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 mortality, heart failure events and quality of life based on Kansas City Cardiomyopathy Questionnaire (KCCQ) calculated at 12 months. KCCQ responses are provided along a rating scale from 0-100 with a higher score indicating better health.
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 14 Aug 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.
James Udelson, MD principal investigator
Tufts Medical Center
93 sites in 14 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 93 sites in 14 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 6 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United States, Spain, Poland, Belgium, Canada and 9 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 Jennifer Olson (+1 612 327 2741, jen.olson@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 14 Aug 2026.