Evaluation of the Alleviant Medical Percutaneously Created Inter-atrial Shunt on Heart Failure Symptoms in Patients with Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fractio

Not Applicable

• Conditions: Heart Failure; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12620001213932
• Lead Sponsor: Alleviant Medical Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-16
• Last Update Posted: 24 November 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Candidates for the study must meet all of the following inclusion criteria at
screening:
1. Documented history of NYHA Class II, Class III or ambulatory Class IV at the screening visit.
2. History of at least one hospitalization for treatment of heart failure within the past 12 months.
3. LVEF greater than or equal to 40% as measured by the study-specific transthoracic echocardiography.
4. 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
5. 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

Candidates for the study must be free of all of the following exclusion
criteria at screening:
1. 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.
2. 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.
3. . 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%.
4. Documented as currently requiring dialysis or estimated GFR less than 25ml/min/1.73m2
5. 6-minute walk distance less than 50 m or greater than 450 m performed during screening.
6. Documented atrial fibrillation with ventricular rate greater than 100 BPM at screening.
7. 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%
8. Presence of pulmonary hypertension with PASP greater than or equal to 70 mmHg OR PVR greater than 4 Wood units.
9. Presence of anatomic anomaly that precludes creation of interatrial shunt (including patent foramen ovale, atrial septal defect, target septal thickness greater than 3 mm)
10. SBP greater than 170 mmHg at screening.
11. Documented left ventricular end diastolic diameter greater than 6 cm.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The composite incidence of one or more of the following through the 1-month follow-up visit: major adverse cardiac, cerebrovascular and thromboembolic events (defined as cardiovascular death, embolic stroke, embolic myocardial infarction, pulmonary or arterial embolism, device and/or procedure-related serious adverse cardiac events). This outcome will be assessed by an evaluation of patient history and medical records. [At one month following the shunt procedure (interventional procedure).];Change in supine exercise Pulmonary Capillary Wedge Pressure at peak exercise from baseline to 1 Month post interventional procedure. This outcome is measured by the patient undertaking the Right Heart Catheter procedure.[At one month following the shunt procedure (interventional procedure).]