Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure

Study Overview
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Brief Summary
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This is a prospective, single arm feasibility study to establish safety and performance of the PAS-C System in subjects with heart failure and elevated left atrial pressure.

Official Title
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Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: PAS-C System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Documented chronic, symptomatic heart failure and NYHA Class II, Class III or ambulatory Class IV at the time of screening visit and receiving guideline directed medical therapy. At least one hospitalization or emergency department visit with heart failure as the primary or secondary diagnosis or intravenous diuretic treatment for heart failure or documentation of elevated BNP. LVEF ≥ 40%. Echocardiographic evidence of diastolic dysfunction during the baseline echocardiography: Per baseline exercise right heart catheterization, site measured elevated left atrial pressure with a gradient compared to right atrial pressure. Key Exclusion Criteria: Stroke or thromboembolic event in the past 6 months. Severe or advanced heart failure such as Stage D heart failure, non-ambulatory NYHA Class IV, cardiac index less than 2.0 L/min/m2, LVEDD > 6 cm, or received inotropic therapy for LVEF less than 40% within 6 months prior to enrollment. Any of the following within 3 months prior to enrollment: myocardial infarction, percutaneous cardiac intervention, CABG, cardiac resynchronization therapy, AICD, or indicated for coronary revascularization at the time of enrollment. More than moderate valve disease (mitral, tricuspid, aortic) at the time of enrollment. Chronic pulmonary disease requiring continuous home oxygen or hospitalization within prior 12 months for pulmonary disease. BMI > 40. 6-minute Walk Test distance less than 100 m or greater than 450 m performed during baseline screening, or unable to perform baseline bicycle exercise test. Any of the following at the time of baseline screening: moderate or worse right heart dysfunction, requires dialysis, atrial fibrillation with ventricular rate > 100 bpm, systolic blood pressure greater than 170 mmHg (average of 3 measurements at baseline). Evidence of precapillary pulmonary hypertension defined as PVR > 2 Wood units at rest, TPG > 15 at rest or with exercise, resting RA > 15 mmHg, or RA to PCWP ratio > 0.7 at rest and with exercise. Anatomic anomaly that precludes creation of interatrial shunt.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InterShunt PAS-C<br> | Device: PAS-C System<br>* The InterShunt PAS-C System is a transcatheter system that creates a shunt by excising tissue from the interatrial septum resulting in a left to right atrial shunt that off-loads elevated left atrial pressure, potentially reducing symptoms and improving quality of life. The PAS-C System does not require a permanent implant to maintain patency of the interatrial shunt.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who experience a major adverse cardiac or cerebrovascular event (MACCE) or systemic embolization. | The proportion of subjects who experience a composite MACCE or systemic embolization event. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiogram evidence of interatrial shunt with left to right atrial flow | Proportion of subjects with visible shunt demonstrating left to right atrial flow as determined by echocardiographer | 1 month |