Alleviate-HF-2 Study
Study Details
Study Description
Brief Summary
Patients with heart failure and preserved left ventricular ejection fraction (HFpEF, EF ≥ 50%) or mid-range left ventricular ejection fraction (HFmrEF, 40% < 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 |
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N/A |
Study Design
Outcome Measures
Primary Outcome Measures
- The composite incidence of one or more major adverse cardiac, cerebrovascular and thromboembolic events and change in supine exercise PCWP at peak exercise. [At 1 month and through 12 months]
Defined as cardiovascular death, embolic stroke, embolic myocardial infarction, pulmonary or arterial embolism, device-and/or procedure-related serious adverse cardiac events.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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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..
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LVEF (by Echo) > 40% as measured by the study-specific transthoracic echocardiography.
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Echocardiographic evidence of diastolic dysfunction documented by one or more of the following as measured by the study-specific transthoracic echocardiography protocol:
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LA diameter > 4cm
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LA volume index >28 mL
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Lateral e' <10 cm/s
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Septal e' <8 cm/s
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Lateral E/e' >10
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Septal E/e' >15
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As measured by the study-specific exercise hemodynamic right heart catheterization protocol performed during screening: 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.
Exclusion Criteria:
- Presence of advanced heart failure 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 less than 2.0 L/min/m2.
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Patient is on the cardiac transplant waiting list.
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Inotropic infusion (continuous or intermittent) for EF less than 40% within the past 6 months.
- Presence of moderate or worse valve disease, defined as one or more of the following:
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Moderate or worse mitral valve regurgitation or moderate or worse mitral stenosis.
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Moderate or worse tricuspid valve regurgitation.
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Moderate or worse aortic valve disease defined as moderate or worse AS or AI.
- . Presence of chronic pulmonary disease defined by one or more of the following:
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Requirement for continuous home oxygen use.
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Hospitalization within the past 12 months for treatment of pulmonary disease.
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Significant chronic pulmonary disease defined as FEV1 less than 50%.
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Documented as currently requiring dialysis or estimated GFR less than 25ml/min/1.73m2
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6-minute walk distance less than 50 m or greater than 450 m performed during screening.
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Documented atrial fibrillation with ventricular rate greater than 100 BPM at screening.
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Presence of moderate or worse right heart dysfunction OR RV dysfunction defined as TAPSE less than 14 mm or RVFAC less than or equal to 30%
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Presence of pulmonary hypertension with PASP greater than or equal to 70 mmHg OR PVR greater than 4 Wood units.
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Presence of anatomic anomaly that precludes creation of interatrial shunt (including patent foramen ovale, atrial septal defect, target septal thickness greater than 3 mm)
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SBP greater than 170 mmHg at screening.
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Documented left ventricular end diastolic diameter greater than 6 cm.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Flinders Medical Centre | Adelaide | Australia | ||
2 | Monash Medical Centre | Clayton | Australia | ||
3 | Centre Hospitalier de l'Université de Montréal (CHUM) | Montréal | Canada | ||
4 | Southern District Health Board | Dunedin | New Zealand | ||
5 | Karolinska University Hospital | Stockholm | Sweden |
Sponsors and Collaborators
- Alleviant Medical, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP-0002