Back to resultsAlleviate-HF-1 Study
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 1
Locations
Georgia
Study Type
Interventional
Intervention
ALV1 System
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility 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.
Sites / Locations
- Tbilisi Heart & Vascular
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04583527
First Posted
September 9, 2020
Last Updated
July 26, 2022
Sponsor
Alleviant Medical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04583527
Brief Title
Alleviate-HF-1 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 Preserved or Mid-Range Left Ventricular Ejection Fraction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
August 16, 2021 (Actual)
Study Completion Date
August 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alleviant Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
ALV1 System
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
At one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Tbilisi Heart & Vascular
City
Tbilisi
Country
Georgia
12. IPD Sharing Statement
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Alleviate-HF-1 Study
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