Heart FailureALT-FLOW IINCT05686317
ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System
A study testing Edwards APTURE transcatheter shunt system in people with Heart Failure, run by Edwards Lifesciences at 25 sites in 5 countries.
Trial summary
This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial. 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?
- Edwards APTURE transcatheter shunt system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 25 sitesin 5 countries
- Study dates
- 1 Apr 2023to 31 Aug 2030
- 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
- Symptomatic heart failure
- A primary diagnosis of HFmrEF or HFpEF (LVEF > 40%), and
- NYHA class II to ambulatory NYHA class IV (IVa), and
- Documentation of at least one of the following from the date of initial informed consent or date of enrollment:
- Within the prior 12 months, EITHER:
- HF hospital admission (with HF as the primary or secondary diagnosis)
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- Treatment with intravenous (IV) or intensification of oral diuretics for HF
- Within the prior 6 months, EITHER:
- BNP value > 35 pg/ml in normal sinus rhythm (NSR) or paroxysmal atrial fibrillation (AF)
- BNP > 125 pg/ml for permanent or long-term persistent AF
- NT-proBNP > 125 pg/ml in NSR or paroxysmal AF
- NT-proBNP > 375 pg/ml for permanent or long-term persistent AF d. There is objective evidence of cardiogenic pulmonary congestion based on hemodynamic criteria obtained by right heart catheterization (RHC) at exercise, and confirmed by hemodynamics core lab as: As measured at end-expiration, pulmonary capillary wedge pressure (PCWP) at ≥ 20 Watts exercise (PCWP ≥ 20W) is elevated to ≥ 25 mmHg and exceeds [the corresponding] right atrial pressure (RAP) by ≥ 8 mmHg • In the judgment of the treating physician and the Central Screening Committee the patient is on GDMT for HFpEF/HFmrEF for >30 days prior to screening and baseline assessments, that is expected to be maintained without change for 6 months.
Who cannot join
- Severe heart failure defined as one or more of the below:
- ACC/AHA/ESC Stage D HF, non-ambulatory NYHA Class IV HF
- If Body Mass Index (BMI) < 30, cardiac index < 2.0 L/min/m2
- If BMI ≥ 30, cardiac index < 1.8 L/min/m2
- Inotropic infusion (continuous or intermittent) within the past 6 months
- Patient is on the cardiac transplant waiting list
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- Prior diagnosis of HF with reduced ejection fraction (HFrEF), including patients with improvement in LVEF to > 40%
- Valve disease:
- Degenerative mitral regurgitation > moderate
- Functional or secondary mitral valve regurgitation defined as grade > moderate
- Mitral stenosis > mild
- Primary or secondary tricuspid valve regurgitation defined as grade > moderate
- Aortic valve disease defined as aortic regurgitation grade > moderate or aortic stenosis > moderate
- More than mild right ventricular (RV) dysfunction as determined by the echo core lab, taking into account the following available parameters:
- Tricuspid annular plane systolic excursion (TAPSE) <1.4 cm, or
- RV size ≥ LV size
- Right ventricular ejection fraction (RVEF) < 35%; or
- Imaging or clinical evidence of congestive hepatopathy
- Mean right atrial pressure (mRAP) > 15 mmHg at rest
- Pulmonary vascular resistance (PVR) ≥ 5.0 WU
- BMI ≥ 45
- Myocardial infarction (MI) and/or any therapeutic invasive, non-valvular cardiovascular procedure within past 3 months or current indication for coronary revascularization
- Stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT) or pulmonary embolus within the past 6 months
- Renal insufficiency as determined by creatinine (sCr) level > 2.5 mg/dL or estimated glomerular filtration rate (eGFR) < 25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis
- Performance of the six-minute walk test (6MWT) with a distance < 50m OR > 450m
- Active endocarditis or infection requiring intravenous antibiotics within 3 months
Trial locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
United States17 sites
Medical University of South Carolina Charleston
Charleston, South Carolina, 29425'
The Christ Hospital
Cincinnati, Ohio, 45219
The Ohio State University
Columbus, Ohio, 43210
Ascension Illinois Heart and Vascular Medical Group
Elk Grove, Illinois, 60007
University of California Irvine
Irvine, California, 92868
Kansas University Medical Center
Kansas City, Kansas, 66160
University of California San Diego
La Jolla, California, 92027
Scripps Health
La Jolla, California, 92037
University of Southern California
Los Angeles, California, 90033
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Oregon Health and Science University
Oregon City, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55902
St. Francis Hospital & Heart Center
Roslyn, New York, 11576
University of California San Francisco
San Francisco, California, 94143
Montefiore Medical Center
The Bronx, New York, 10467
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Germany5 sites
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, 32545
Herzzentrum Universitätsklinikum Köln
Cologne, 50937
Herzzentrum Dresden GmbH Universitätsklinik für Innere Medizin und Kardiologie
Dresden, 01307
Universitätsklinikum Heidelberg Medizinische Klinik
Heidelberg, 69120
Johannes Gutenberg Universitaet Mainz
Mainz, 55131
Brazil1 site
Instituto do Coracao da Universidade de Sao Paulo
São Paulo, 05403-900
About this study
Official title: A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW II)
This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.
Read the detailed description
The objectives of this trial are to assess the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system when used for the treatment of patients with heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction (LVEF >40%) who remain symptomatic despite guideline-directed medical therapy (GDMT)
- Conditions
- Heart Failure
- Being tested
- Edwards APTURE transcatheter shunt system, Sham procedure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards APTURE transcatheter shunt systemDevice
Treatment with APTURE shunt
Sham procedureDiagnostic test
CS angiography
| Study group | Role | What they receive |
|---|---|---|
| APTURE shunt + medical therapy | Experimental | Not described Receives: Device: Edwards APTURE transcatheter shunt system |
| Sham + medical therapy | Sham comparator | Not described Receives: Diagnostic Test: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device + Medical Therapy: Subjects with Early Major Adverse Events
Shunt implant safety: proportion of patients in the APTURE shunt group without any serious device or procedure-related (CEC adjudicated) complications (i.e., Major Adverse Cardiovascular, Cerebrovascular, and Renal Events [MACCRE]; at 30 days post index procedure or hospital discharge, whichever is later.
Measured: 30 days
Mean change in PCWL from baseline at 6 months
Hemodynamic Effectiveness: change in pulmonary capillary wedge during load (PCWL, mmHg/W/kg) from baseline at 6 months.
Measured: 6-months
Secondary outcomes (3)
KCCQ-OSS change from baseline at 6-month follow-up
Change in Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OSS) from baseline at 6-month follow-up.
Measured: 6-months
Proportion of individual patient success defined as being free from death, disabling stroke, and HF hospitalization with at least (≥) a 15-point improvement from baseline KCCQ-OSS or at least (≥) a 25m improvement from baseline 6MWT.
Measured: 6-months
6MWT change from baseline at 6-month follow-up
Chang in 6-Minute Walk Test (6MWT) from baseline at 6-month follow-up
Measured: 6-months
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 start1 Apr 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Aug 2030 (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.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686317
- Sponsor's protocol ID
- 2022-06
- Acronym
- ALT-FLOW II
- Status last verified
- Jun 2026
- First submitted
- 6 Jan 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW II)
- ClinicalTrials.gov ID
- NCT05686317
- Acronym / sponsor ID
- ALT-FLOW II / 2022-06
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Aug 2030 (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.
This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.
Detailed description
The objectives of this trial are to assess the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system when used for the treatment of patients with heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction (LVEF >40%) who remain symptomatic despite guideline-directed medical therapy (GDMT)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APTURE shunt + medical therapy | Experimental | Device: Edwards APTURE transcatheter shunt system |
| Sham + medical therapy | Sham comparator | Diagnostic Test: Sham procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Symptomatic heart failure
- A primary diagnosis of HFmrEF or HFpEF (LVEF > 40%), and
- NYHA class II to ambulatory NYHA class IV (IVa), and
- Documentation of at least one of the following from the date of initial informed consent or date of enrollment:
- Within the prior 12 months, EITHER:
Key exclusion criteria (26 listed)
- Severe heart failure defined as one or more of the below:
- Valve disease:
- More than mild right ventricular (RV) dysfunction as determined by the echo core lab, taking into account the following available parameters:
- Mean right atrial pressure (mRAP) > 15 mmHg at rest
- Pulmonary vascular resistance (PVR) ≥ 5.0 WU
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 |
|---|---|---|
| Edwards APTURE transcatheter shunt systemTreatment with APTURE shunt | Device | APTURE shunt + medical therapy |
| Sham procedureCS angiography | Diagnostic test | Sham + medical therapy |
Primary outcome
Device + Medical Therapy: Subjects with Early Major Adverse Events
Time frame: 30 days
Shunt implant safety: proportion of patients in the APTURE shunt group without any serious device or procedure-related (CEC adjudicated) complications (i.e., Major Adverse Cardiovascular, Cerebrovascular, and Renal Events [MACCRE]; at 30 days post index procedure or hospital discharge, whichever is later.
Mean change in PCWL from baseline at 6 months
Time frame: 6-months
Hemodynamic Effectiveness: change in pulmonary capillary wedge during load (PCWL, mmHg/W/kg) from baseline at 6 months.
3 secondary outcomes
KCCQ-OSS change from baseline at 6-month follow-up
Time frame: 6-months
Proportion of individual patient success defined as being free from death, disabling stroke, and HF hospitalization with at least (≥) a 15-point improvement from baseline KCCQ-OSS or at least (≥) a 25m improvement from baseline 6MWT.
Time frame: 6-months
6MWT change from baseline at 6-month follow-up
Time frame: 6-months
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 4 Jun 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edwards APTURE transcatheter shunt system in people with Heart Failure, run by Edwards Lifesciences at 25 sites in 5 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 12 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Germany, Brazil, Canada, Switzerland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device + Medical Therapy: Subjects with Early Major Adverse Events (time frame: 30 days). The study lists 2 primary outcomes in all. 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 4 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.