Heart FailureALT-FLOW HFrEFNCT07858799
Early Feasibility Study 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 3 sites in Germany.
Trial summary
The objectives of this early feasibility study are to: evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system for treatment of symptomatic HFrEF patients with elevated LAP, provide guidance for future clinical study and system designs utilizing the APTURE system. 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?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesGermany
- Study dates
- Oct 2026to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Refined HFrEF Subgroup Inclusion Criteria:
- A primary diagnosis of HFrEF (LVEF ≤ 40%), and
- NYHA Class II, III, or IVa heart failure symptoms and
- Documentation of at least one of the following in the past 12 months, such as:
- Hospitalization for heart failure; or
- Increased treatment for heart failure, including intravenous (IV) or higher-dose diuretic therapy.
- Elevated heart failure biomarker levels (BNP or NT-proBNP) within the past 6 months.
Note: Participants with NYHA Class II symptoms must have both a recent heart failure worsening event and elevated biomarker levels. Participants with NYHA Class III or IVa symptoms must have either a recent heart failure worsening event or elevated biomarker levels.
- Stable Optimized GDMT- Maintained 6 months post-implant (includes stable GLP-1 RA), indicated device therapy, and comorbidity management.
Refined HFrEF Subgroup Exclusion Criteria:
- Severe HF defined as one or more of the following:
- Ambulatory NT-proBNP value >5,000 pg/ml or BNP value >1,600 pg/ml
- Left ventricular end-diastolic diameter (LVEDD) >8 cm
- Left ventricular ejection fraction (LVEF) < 20%
- ACC/AHA Stage D HF or non-ambulatory NYHA Class IV HF
- Inotropic infusion (continuous or intermittent) within the past 6 months
- Active listing on the cardiac transplant waiting list
- More than mild right ventricular dysfunction
- Valve disease
- Mitral regurgitation > moderate
- Mitral stenosis > mild
- Tricuspid regurgitation > moderate
- Aortic regurgitation > moderate
- Aortic stenosis > moderate
- Body mass index (BMI) ≥45
- Myocardial infarction and/or any therapeutic invasive, non-valvular cardiac procedure within the past 3 months, or current indication for coronary revascularization
- Stroke, transient ischemic attack, deep vein thrombosis, or pulmonary embolus within the past 6 months
- Cardiac resynchronization therapy implanted within the past 12 months, or unmet guideline-directed indication for CRT
- Renal insufficiency as determined by serum creatinine (sCr) level >2.5 mg/dL or estimated glomerular filtration rate (eGFR) <25 ml/min/1.73 m2
- Performance of the 6-minute walk test with a distance <100 m or >450 m
- Active endocarditis or infection requiring intravenous antibiotics within 3 months of scheduled index procedure
- Presence of one or more of the following resting hemodynamic findings:
- Mean pulmonary capillary wedge pressure (PCWP) >35 mmHg
- Mean right atrial pressure (RAP) >15 mmHg
- Mean PCWP-mean RAP gradient < 5 mmHg
- Pulmonary vascular resistance (PVR) ≥5 Wood Units (WU)
- Cardiac index <1.8 L/min/m2
- Baseline resting heart rate >100 bpm
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Not yet recruiting
Herzzentrum Universitätsklinikum Köln
Cologne, Germany, 50937
Ana Heinrichs, (+49) 221-47832417, ana.heinrichs@uk-koeln.de
Roman Pfister, MD
- Recruiting
Herzzentrum Dresden GmbH Universitätsklinik für Innere Medizin und Kardiologie
Dresden, Germany, 01307
Jennifer Hommel, +49 351-45025237, jennifer.hommel@tu-dresden.de
Axel Linke, MD
- Recruiting
Johannes Gutenberg Universitaet Mainz
Mainz, Germany, 55131
Janina Mannweiler, +49-6131-17-6248, janina.mannweiler@unimedizin-mainz.de
Philipp Lurz, MD
About this study
Official title: Early Feasibility Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW HFrEF (DE))
The objectives of this early feasibility study are to: evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system for treatment of symptomatic HFrEF patients with elevated LAP, provide guidance for future clinical study and system designs utilizing the APTURE system.
Read the detailed description
This is a prospective, multi-center, open-label, single-arm, early feasibility study to evaluate the safety and performance of the APTURE system for the treatment of symptomatic HFrEF patients with elevated LAP.
- Conditions
- Heart Failure
- Being tested
- Edwards APTURE transcatheter shunt system
- 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
Transcatheter treatment of symptomatic heart failure patients with elevated left atrial pressure (LAP).
| Study group | Role | What they receive |
|---|---|---|
| Edwards APTURE transcatheter shunt system | Experimental | Not described Receives: Device: Edwards APTURE transcatheter shunt system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)
Composite of device- or procedure-related major adverse cardiovascular, cerebrovascular, and renal events (MACCRE) at 30 days post implant procedure or hospital discharge, whichever is later.
Measured: 30 days
Secondary outcomes (1)
Change in KCCQ Overall Summary Score (Performance Endpoint)
Change in KCCQ-OSS from baseline to 6 months.
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 posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT07858799
- Sponsor's protocol ID
- 2026-01
- Acronym
- ALT-FLOW HFrEF
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW HFrEF (DE))
- ClinicalTrials.gov ID
- NCT07858799
- Acronym / sponsor ID
- ALT-FLOW HFrEF / 2026-01
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 5 Oct 2026 (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.
The objectives of this early feasibility study are to: evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system for treatment of symptomatic HFrEF patients with elevated LAP, provide guidance for future clinical study and system designs utilizing the APTURE system.
Detailed description
This is a prospective, multi-center, open-label, single-arm, early feasibility study to evaluate the safety and performance of the APTURE system for the treatment of symptomatic HFrEF patients with elevated LAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edwards APTURE transcatheter shunt system | Experimental | Device: Edwards APTURE transcatheter shunt system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 systemTranscatheter treatment of symptomatic heart failure patients with elevated left atrial pressure (LAP). | Device | Edwards APTURE transcatheter shunt system |
Primary outcome
Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)
Time frame: 30 days
Composite of device- or procedure-related major adverse cardiovascular, cerebrovascular, and renal events (MACCRE) at 30 days post implant procedure or hospital discharge, whichever is later.
1 secondary outcome
Change in KCCQ Overall Summary Score (Performance Endpoint)
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 5 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.
3 sites in 1 country: 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 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 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 3 sites in Germany. 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. 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 Natalie Alon (949-250-1898, Natalie_Alon@edwards.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint) (time frame: 30 days). 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 5 Oct 2026.