PAS-C System for Heart Failure

(EASE HF2 Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: InterShunt Technologies, Inc.

Must be taking: Heart failure therapy

Disqualifiers: Stroke, Myocardial infarction, Chronic pulmonary, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

20 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on maximally tolerated guideline-directed medical therapy for heart failure management, which suggests you may need to continue your current heart failure medications.

What data supports the effectiveness of the PAS-C System treatment for heart failure?

The research suggests that specialized care systems, including those with strong nursing components and multidisciplinary teams, improve outcomes for heart failure patients by reducing hospital readmissions and enhancing adherence to treatment guidelines. This indicates that structured care systems, like the PAS-C System, may be effective in managing heart failure. ^{1 2 3 4 5}

How is the PAS-C System treatment different from other heart failure treatments?

The PAS-C System, also known as the C-Pulse, is unique because it is an implantable device that provides extra-aortic counterpulsation, which helps the heart by reducing the workload and improving blood flow without the need for blood thinners. Unlike other treatments, it does not require open-heart surgery and has a lower risk of complications like strokes or major bleeding. ^{6 7 8 9 10}

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

Resting right heart catheterization demonstrates elevated PCWP compared to right atrial pressure

LVEF ≥ 20% and ≤ 40% according to baseline echocardiography

I am on the strongest recommended treatment for heart failure.

Exclusion Criteria

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

Patent foramen ovale (PFO) device or atrial septal defect (ASD) device

I have had a recent heart issue or procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a procedure using the PAS-C System to create an interatrial shunt

1 day

1 visit (in-person)

Follow-up

Participants are monitored for major adverse cardiac or cerebrovascular events or systemic embolization

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• PAS-C System

Trial Overview 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.

Participant Groups

Group I: PAS-C System Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

InterShunt Technologies, Inc.

Lead Sponsor

Trials

2

Recruited

30+

Findings from Research

Natriuretic peptide (NP)-guided therapy significantly reduced overall mortality and heart failure (HF)-related hospital admissions in chronic heart failure patients, based on a systematic review of nine randomized clinical trials involving 1914 patients.

While NP-guided therapy showed benefits, the presence of clinical heterogeneity among the studies suggests that specific interventions should be carefully considered before making broad recommendations for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of natriuretic peptide-guided treatment of chronic heart failure. A meta-analysis. Gamiño-Arroyo, AE., Prado-Galbarro, FJ., García-Pérez, S., et al.[2019]

The HeartCon left ventricular assist device (LVAD) significantly improved heart function and quality of life in 20 adult patients with end-stage heart failure, as evidenced by reductions in left ventricular end-diastolic diameter and increases in left ventricular ejection fraction after 90 days.

The procedure was safe, with no mechanical failures reported and a low incidence of serious complications, although further studies are needed to assess long-term effects and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Short-term effect of HeartCon left ventricular assist device on the treatment of 20 adult patients with end-stage heart failure]. Wang, W., Song, Y., Zhang, Y., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

What is the impact of systems of care for heart failure on patients diagnosed with heart failure: a systematic review. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Nursing care and education in heart failure. [2016]

3. Mexico pubmed.ncbi.nlm.nih.gov

Effectiveness of natriuretic peptide-guided treatment of chronic heart failure. A meta-analysis. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Essential components in natriuretic peptide-guided management of heart failure: an intervention synthesis. [2022]

5. Portugal pubmed.ncbi.nlm.nih.gov

Specialized acute care and heart failure management programs. [2008]

6. United States pubmed.ncbi.nlm.nih.gov

Ambulatory extra-aortic counterpulsation in patients with moderate to severe chronic heart failure. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Sunshine Heart C-Pulse: device for NYHA Class III and ambulatory Class IV heart failure. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Preliminary Results From the C-Pulse OPTIONS HF European Multicenter Post-Market Study. [2018]

9. China pubmed.ncbi.nlm.nih.gov

[Short-term effect of HeartCon left ventricular assist device on the treatment of 20 adult patients with end-stage heart failure]. [2023]

10. Slovakia pubmed.ncbi.nlm.nih.gov

Successful support of biventricular heart failure in an adult patient by the Berlin Heart EXCOR system as a bridge to transplant: literature review. [2023]