PAS-C System for Heart Failure (EASE HF2 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: InterShunt Technologies, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with heart failure who may benefit from a new device called the PAS-C System. It's an early study to see if it's safe and can help with symptoms. Participants should meet specific health conditions, but those details aren't provided here.

Inclusion Criteria

I am on the strongest recommended treatment for heart failure.

My heart condition limits my physical activity but I can still perform light tasks.

Exclusion Criteria

I need oxygen at home or was hospitalized for lung problems in the last year.

I cannot have a heart shunt due to an anatomical issue.

I am scheduled for a heart procedure within the next 6 months.

I haven't had a stroke, severe heart issues, or specific heart treatments in the last 6 months.

My BMI is over 40.

Participant Groups

The PAS-C System, a device designed for percutaneous shunting of the interatrial septum, is being tested for its safety and potential to improve heart failure symptoms. This initial study could lead to further research based on its results.

1Treatment groups

Experimental Treatment

Group I: PAS-C SystemExperimental Treatment1 Intervention

The PAS-C System is a catheter designed to removal a small section of septal tissue in the interatrial septum to treat heart failure patients without the need for a permanent implant.