PAS-C System for Heart Failure

(EASE HF2 Trial)

Recruiting at 5 trial locations

Overseen By Lisa Ingham

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the PAS-C System, designed to help people with heart failure feel better without a permanent implant. The goal is to determine if the device is safe and can ease heart failure symptoms by creating a small opening between the heart's upper chambers. It suits those who have struggled with heart failure for over six months, have had hospital visits or special treatments for heart failure, and are on heart failure medications.

As an unphased trial, it offers a unique opportunity to contribute to innovative heart failure research and potentially benefit from cutting-edge technology.

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 prior data suggests that the PAS-C System is safe for heart failure patients?

Research has shown that the PAS-C System is being tested as a new method to assist people with heart failure. This device uses a thin tube to create a small opening in the heart's septum, the wall between the heart's left and right sides. The goal is to improve heart failure symptoms without requiring a permanent implant.

Studies of similar devices, such as the second-generation V-Wave system, have indicated that these devices are generally well-tolerated. However, some patients experienced mixed results, with both positive effects and some challenges.

As an early feasibility study, the trial for the PAS-C System focuses on carefully assessing the device's safety. This means the study is in the initial testing stages to ensure its safety for use. While detailed safety data for this specific device is not yet available, initial human testing suggests confidence in its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The PAS-C System is unique because it treats heart failure by removing a small section of tissue in the heart's septum without needing a permanent implant. This is a big leap from current treatments like medications, lifestyle changes, or invasive procedures that often involve placing devices in the heart. The PAS-C System's catheter-based approach might offer a less invasive alternative with potentially lower risks and quicker recovery times. Researchers are excited about this treatment because it could offer a new way to manage heart failure while minimizing long-term complications associated with implants.

What evidence suggests that the PAS-C System is effective for heart failure?

Research has shown that devices like the PAS-C System, studied in this trial, may help treat heart failure. Studies have found that these devices can improve heart function by increasing the amount of blood the heart pumps and enhancing overall heart performance. Patients reported being able to walk longer distances in six minutes, indicating better endurance and heart health. Another study with a different device showed similar positive results over a year, with participants experiencing improved heart health and safety. These findings suggest that devices focusing on the heart's septum might help reduce heart failure symptoms. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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

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

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

I have had a recent heart issue or procedure.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. withpower.com withpower.com/trial/pas-c-system-for-heart-failure-0e7df

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

2. jacc.org jacc.org/doi/10.1016/j.jchf.2023.07.002

Device Interventions for Heart Failure In this study, the VisONE ASD system resulted in an acute improvement in cardiac output and LVEF along with improvement in 6MWD with no ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11232059/

Interatrial Shunt Devices - PMC - PubMed Central - NIH Subsequently, the 1-year results with 53 patients (24 patients with HFrEF and 29 patients with HFpEF) showed consistent results related to efficacy, safety, and ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.124.012754

Relationship Between Remote, Ambulatory Pulmonary ... The specific aims of this retrospective analysis were to use a combined database consisting of 5 clinical trials: CHAMPION (CardioMEMS Heart ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ejhf.3687?af=R

A systematic review and meta‐analysis of real‐world ... Heart failure management with CardioMEMS leads to lower PAP, improved functional status and quality of life, and decrease of HFHs at 1 year.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170011B.pdf

summary of safety and effectiveness data (ssed) effectiveness of the Impella RP System in patients who developed acute right heart failure or ... The Impella RP System PAS was a prospective, multi-center, non- ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772930324021069

Implications for Interatrial Shunt Device Therapy in Heart ... (C) Oblique four-chamber view shows flow from the left atrium crossing into ... Although preliminary data for interatrial shunt devices in HF showed mixed results ...