Heart Failure
Conditions
Brief summary
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.
Interventions
DEVICEPAS-C System
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.
Sponsors
InterShunt Technologies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects who experience a major adverse cardiac or cerebrovascular event (MACCE) or systemic embolization. | 1 month | The proportion of subjects who experience a composite MACCE or systemic embolization event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiogram evidence of interatrial shunt with left to right atrial flow | 1 month | Proportion of subjects with visible shunt demonstrating left to right atrial flow as determined by echocardiographer |
Countries
Georgia
Outcome results
None listed