Alleviate-HF-1 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 |
|---|---|---|
|
Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- The composite incidence of one or more of the following through the 1-month follow-up visit: major adverse cardiac, cerebrovascular and thromboembolic events. [At one month]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Documented history of NYHA Class II, Class III or ambulatory Class IV at the screening visit.
-
History of at least one hospitalization for treatment of heart failure within the past 12 months.
-
LVEF greater than 40% as measured by the study-specific transthoracic echocardiography.
-
Echocardiographic evidence of diastolic dysfunction documented by one or more of the following as measured by the study-specific transthoracic echocardiography protocol performed during screening:
-
LA diameter greater than 4 cm
-
LA volume index greater than 28 mL
-
Lateral e' less than 10 cm/s
-
Septal e' less than 8 cm/s
-
Lateral E/e' greater than 10
-
Septal E/e' greater than 15
- 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 greater than or equa. to 25 mmHg AND (2) PCWP greater than RAP by greater than or equal to 5 mmHg, OR greater than or equal to 10 mmHg increase of end-expiratory PCWP at peak supine cycle ergometer exercise compared to resting PCWP AND PCWP greater than RAP by greater than or equal to 5 mmHg.
Exclusion Criteria:
- Presence of advanced heart failure defined as one or more of the following:
-
ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF.
-
Cardiac index less than 2.0 L/min/m2.
-
Patient is on the cardiac transplant waiting list.
-
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:
-
Moderate or worse mitral valve regurgitation or moderate or worse mitral stenosis.
-
Moderate or worse tricuspid valve regurgitation.
-
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:
-
Requirement for continuous home oxygen use.
-
Hospitalization within the past 12 months for treatment of pulmonary disease.
-
Significant chronic pulmonary disease defined as FEV1 less than 50%.
-
Documented as currently requiring dialysis or estimated GFR less than 25ml/min/1.73m2
-
6-minute walk distance less than 50 m or greater than 450 m performed during screening.
-
Documented atrial fibrillation with ventricular rate greater than 100 BPM at screening.
-
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%
-
Presence of pulmonary hypertension with PASP greater than or equal to 70 mmHg OR PVR greater than 4 Wood units.
-
Presence of anatomic anomaly that precludes creation of interatrial shunt (including patent foramen ovale, atrial septal defect, target septal thickness greater than 3 mm)
-
SBP greater than 170 mmHg at screening.
-
Documented left ventricular end diastolic diameter greater than 6 cm.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tbilisi Heart & Vascular | Tbilisi | Georgia |
Sponsors and Collaborators
- Alleviant Medical, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP-0001