ALLEVIATE-HF-HD Study
Study Details
Study Description
Brief Summary
Patients with heart failure and reduced left ventricular ejection fraction (HFrEF, EF 25-39%), or mid-range left ventricular ejection fraction (HFmrEF, EF 40-49%), or preserved left ventricular ejection fraction (HFpEF, EF ≥ 50%), 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- Primary Safety Endpoint [1-Month]
The composite incidence of one or more of the following through the 1-month follow-up visit: major adverse cardiac, cerebrovascular and thromboembolic events.
- Primary Efficacy Endpoint [1-Month]
Change in supine exercise PCWP at 25-watts exercise from baseline to Month 1.
Eligibility Criteria
Criteria
Inclusion Criteria:
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NYHA class II if a prior history of > NYHA class II; OR NYHA class III; OR ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit.
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Within 12 months of study entry: ≥ 1 HF hospital admission (with HF as the primary or secondary diagnosis); OR treatment with IV diuretics; OR an NT-pro BNP value > 150 pg/ml in normal sinus rhythm, > 450 pg/ml in atrial fibrillation, or a BNP value > 50 pg/ml in normal sinus rhythm, > 150 pg/ml in atrial fibrillation within the past 6 months.
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Site determined echocardiographic LVEF > 25% as measured by the study specific screening transthoracic echo.
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Site determined hemodynamic criteria assessed by the screening supine bicycle exercise right heart catheterization test, including each of the components (a)-(b) below:
- At rest: i. RAP < 14 mmHg ii. PVR < 3.5 Wood units iii. PAS < 70 mmHg iv. Cardiac Index > 1.9 L/min b. At exercise (25-watts): i. PCWP must have a gradient > 5 mmHg of the RA ii. End-expiratory PCWP ≥ 25 mmHg iii. PVR < 1.8 Wood units [if PVR cannot be obtained (e.g., patient stopped pedaling), TPG < 12 mmHg]
Exclusion Criteria:
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Presence of advanced heart failure documented in the medical history, defined as one or more of the following:
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ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
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Cardiac index < 2.0 L/min/m2
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Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months
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Patient is on the cardiac transplant waiting list.
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Presence of uncorrected valve disease documented in the medical history and/or confirmed by the study-specific TTE protocol performed during screening, defined as one or more of the following:
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Greater than moderate mitral regurgitation
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Greater than moderate mitral stenosis
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Greater than mild tricuspid regurgitation
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Greater than moderate aortic stenosis
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Greater than moderate aortic regurgitation
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Presence of clinically significant untreated carotid artery stenosis documented in the medical history that is likely to require intervention.
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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 angina or other evidence of coronary ischemia.
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Presence of hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other infiltrative cardiomyopathy such as hemochromatosis or sarcoidosis.
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Presence of uncontrolled tachyarrhythmia documented in the medical history.
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Medical history of one or more of the following cardiac procedures:
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MI and/or percutaneous coronary intervention (PCI) within the past 3 months
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CABG within the past 3 months
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SAVR or TAVR within the past 6 months
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MVR or TMVR within the past 6 months
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Medical history of any implanted pacemaker device.
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Medical history of cardiac ablation procedure (either for atrial or ventricular arrhythmias) within the past 3 months.
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Presence of chronic pulmonary disease documented in the medical history, defined by one or more of the following:
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Current requirement for continuous home oxygen use
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Hospitalization within the past 12 months for treatment of chronic pulmonary disease
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Significant chronic pulmonary disease defined as FEV1 < 50% of predicted
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If COPD is documented in the medical history and the patient is taking oral or inhaled COPD medication at the time of screening, then a spirometry test is to be performed and patient excluded if FEV1 < 50%.
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Presence of pulmonary hypertension with PASP ≥ 70 mmHg OR PVR > 3.5 Wood units at rest, documented in the medical history or diagnosed during the initial right heart catheterization.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tbilisi Heart and Vascular | Tbilisi | Georgia |
Sponsors and Collaborators
- Alleviant Medical, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP-0005