An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
InterShunt Technologies, Inc.
Summary
The purpose of this early feasibility study is to evaluate the safety and feasibility of the device for percutaneous shunting of the interatrial septum and improvement of heart failure related symptoms. The primary goal is to determine if the device is safe to use. The findings from this study may be used to refine the intended patient population, the design of the device, or develop a subsequent randomized study.
Description
This is a prospective, multicenter, single-arm early feasibility study (EFS) to evaluate the safety of the InterShunt PAS-C System in subjects with heart failure, and the feasibility of PAS-C to improve heart failure related symptoms. The device is used to create an interatrial shunt by removing septal tissue to reduce left atrial pressure. There is no permanent implant. Enrollment will include 20 subjects with documented heart failure who may benefit from the reduction of left atrial pressure. The primary objective of this study is to characterize the safety of using the PAS-C System by evalu…
Eligibility
- Age range
- 40–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * NYHA Class II at screening with a prior history of greater than NYHA Class II, OR NYHA Class III at screening, OR ambulatory Class IV at screening: with documented medical history of heart failure for at least 6 months prior to the screening visit. * At least one hospitalization for heart failure OR treatment with IV diuretics for heart failure OR elevated BNP in the prior 12 months. * Receiving maximally tolerated guideline directed medical therapy for Heart Failure management. * LVEF ≥ 20% and ≤ 40% according to baseline echocardiography. * Resting right heart catheter…
Interventions
- DevicePAS-C System
All patients will undergo catheterization with the PAS-C System to create an interatrial shunt to reduce left atrial pressure in the heart.
Locations (6)
- St. Bernard's HealthcareJonesboro, Arkansas
- Los Robles Health SystemThousand Oaks, California
- Ascension St. Vincent HospitalIndianapolis, Indiana
- Christ HospitalCincinnati, Ohio
- The Ohio State UniversityColumbus, Ohio
- Methodist HealthcareSan Antonio, Texas