Heart FailurePhase 1NCT05133089
ALLEVIATE-HFrEF Study
A Phase 1 study testing ALV1 System in people with Heart Failure, run by Alleviant Medical, Inc. at 1 site in Georgia.
Trial summary
Patients with heart failure and reduced left ventricular ejection fraction (HFrEF, EF ≤ 40%) with mild to moderate functional limitation will be evaluated for treatment via creation of a no-implant interatrial shunt using clinical, echocardiographic, and invasive hemodynamic data. 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?
- ALV1 System
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteGeorgia
- Study dates
- 10 Aug 2021to 1 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- NYHA Class II at screening with a prior history of greater than NYHA Class II, OR NYHA Class III at screening, OR ambulatory Class IV at screening: with documented medical history of heart failure for at least 6 months prior to the screening visit.
- Medical history within the past 12 months of at least one hospitalization with heart failure as the primary or secondary diagnosis OR treatment with IV diuretics for heart failure.
- Calculated LVEF (by Echo) ≤ 40% as measured by the study-specific transthoracic echocardiography.
- Elevated left atrial pressure WITH a gradient compared to right atrial pressure (RAP) documented by: (1) end-expiratory PCWP at peak supine cycle ergometer exercise ≥ 25mmHg AND (2) PCWP greater than RAP by ≥ 5 mmHg, OR (1) ≥ 10 mmHg increase of end-expiratory PCWP at peak supine cycle ergometer exercise compared to resting PCWP AND (2) PCWP greater than RAP by ≥ 5 mmHg. Patients must also have PCWP greater than RAP by ≥ 5 mmHg at rest.
Who cannot join
- Presence of advanced heart failure documented in the medical history, defined as one or more of the following:
- ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF.
- Cardiac index <1.5 L/min/m2.
- Patient is on the cardiac transplant waiting list. CIP-0004 Rev 01 - ALLEVIATE-HFrEF Study Confidential Alleviant Medical, Inc. Page 9 of 64
- Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months.
- History of mechanical cardiac support within 6 months.
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- Presence of moderate or worse uncorrected valve disease documented in the medical history and/or confirmed by the study-specific transthoracic echocardiography protocol performed during screening, defined as one or more of the following:
- Moderate or worse degenerative mitral valve regurgitation or moderate or worse mitral stenosis.
- Severe functional mitral regurgitation.
- Moderate or worse tricuspid valve regurgitation.
- Moderate or worse aortic valve disease defined as moderate or worse aortic stenosis.
- Severe aortic regurgitation.
- Presence of clinically significant untreated carotid artery stenosis documented in the medical history that is likely to require intervention.
- Presence of clinically significant un-revascularized coronary artery disease documented in the medical history that is likely to require intervention, defined as epicardial coronary artery stenosis associated with frequent angina not well controlled with medical therapy or other evidence of coronary ischemia.
- Presence of infiltrative or hypertrophic cardiomyopathy documented in the medical history.
- Presence of uncontrolled tachyarrhythmia documented in the medical history.
- Medical history ofone or more of the following cardiac procedures:
- MI and/or percutaneous coronary intervention (PCI) within the past 3 months;
- CABG within the past 3 months;
- SAVR or TAVR within the past 6 months;
- MVR or TMVR within the past 6 months;
- Medical history of cardiac resynchronization therapy within the past 6 months or any implanted pacemaker device (or leads) placed within the past 6 months.
- Medical history of lead revision or ablation procedure (either for atrial or ventricular arrhythmias) within the past 3 months.
- Presence of chronic pulmonary disease documented in the medical history, defined by one or more of the following:
- Current requirement for continuous home oxygen use.
- Hospitalization within the past 12 months for treatment of chronic pulmonary disease.
- Significant chronic pulmonary disease defined as FEV1 < 50%.
- Presence of pulmonary hypertension with PASP ≥ 70 mmHg OR PVR > 4 Wood units, documented in the medical history.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Feasibility of a Percutaneously Created Interatrial Shunt to Alleviate Heart Failure Symptoms in Patients With Chronic Heart Failure and Reduced Left Ventricular Ejection Fraction
Patients with heart failure and reduced left ventricular ejection fraction (HFrEF, EF ≤ 40%) with mild to moderate functional limitation will be evaluated for treatment via creation of a no-implant interatrial shunt using clinical, echocardiographic, and invasive hemodynamic data.
- Conditions
- Heart Failure
- Being tested
- ALV1 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.
ALV1 SystemDevice
The ALV1 system is designed to create a controlled size interatrial shunt via a proprietary intra-cardiac catheter. There is no temporary or permanent implant used to create or maintain the interatrial shunt. The therapy is intended to be delivered in a single procedure administered under general anesthesia in a cardiac catheterization laboratory.
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite incidence of one or more of the following through the 1-month follow-up visit: major adverse cardiac, cerebrovascular and thromboembolic events.
Measured: 1-Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start10 Aug 2021
- Primary completion10 Mar 2022
- Study completion1 Jun 2022
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alleviant Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133089
- Sponsor's protocol ID
- CIP-0004
- Status last verified
- Jul 2022
- First submitted
- 12 Nov 2021
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Feasibility of a Percutaneously Created Interatrial Shunt to Alleviate Heart Failure Symptoms in Patients With Chronic Heart Failure and Reduced Left Ventricular Ejection Fraction
- ClinicalTrials.gov ID
- NCT05133089
- Acronym / sponsor ID
- CIP-0004
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Alleviant Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 24 Nov 2021 (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.
Patients with heart failure and reduced left ventricular ejection fraction (HFrEF, EF ≤ 40%) with mild to moderate functional limitation will be evaluated for treatment via creation of a no-implant interatrial shunt using clinical, echocardiographic, and invasive hemodynamic data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- NYHA Class II at screening with a prior history of greater than NYHA Class II, OR NYHA Class III at screening, OR ambulatory Class IV at screening: with documented medical history of heart failure for at least 6 months prior to the screening visit.
- Medical history within the past 12 months of at least one hospitalization with heart failure as the primary or secondary diagnosis OR treatment with IV diuretics for heart failure.
- Calculated LVEF (by Echo) ≤ 40% as measured by the study-specific transthoracic echocardiography.
- Elevated left atrial pressure WITH a gradient compared to right atrial pressure (RAP) documented by: (1) end-expiratory PCWP at peak supine cycle ergometer exercise ≥ 25mmHg AND (2) PCWP greater than RAP by ≥ 5 mmHg, OR (1) ≥ 10 mmHg increase of end-expiratory PCWP at peak supine cycle ergometer exercise compared to resting PCWP AND (2) PCWP greater than RAP by ≥ 5 mmHg. Patients must also have PCWP greater than RAP by ≥ 5 mmHg at rest.
Key exclusion criteria (28 listed)
- Presence of advanced heart failure documented in the medical history, defined as one or more of the following:
- Presence of moderate or worse uncorrected valve disease documented in the medical history and/or confirmed by the study-specific transthoracic echocardiography protocol performed during screening, defined as one or more of the following:
- Presence of clinically significant untreated carotid artery stenosis documented in the medical history that is likely to require intervention.
- Presence of clinically significant un-revascularized coronary artery disease documented in the medical history that is likely to require intervention, defined as epicardial coronary artery stenosis associated with frequent angina not well controlled with medical therapy or other evidence of coronary ischemia.
- Presence of infiltrative or hypertrophic cardiomyopathy documented in the medical history.
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 |
|---|---|---|
| ALV1 SystemThe ALV1 system is designed to create a controlled size interatrial shunt via a proprietary intra-cardiac catheter. There is no temporary or permanent implant used to create or maintain the interatrial shunt. The therapy is intended to be delivered in a single procedure administered under general anesthesia in a cardiac catheterization laboratory. | Device | – |
Primary outcome
The composite incidence of one or more of the following through the 1-month follow-up visit: major adverse cardiac, cerebrovascular and thromboembolic events.
Time frame: 1-Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALV1 System in people with Heart Failure, run by Alleviant Medical, Inc. at 1 site in Georgia.
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 4 inclusion and 28 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: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The composite incidence of one or more of the following through the 1-month follow-up visit: major adverse cardiac, cerebrovascular and thromboembolic events. (time frame: 1-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 18 Jul 2023.