Transcatheter Shunt for Heart Failure

Recruiting at 2 trial locations

Overseen By Ana Gonzalez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Must be taking: GDMT for HF

Disqualifiers: Severe HF, Valve disease, MI, others

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

Compensation: Varies

Number of Visits: 3

Duration: 10 days

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new device called the Edwards APTURE transcatheter shunt system for individuals with heart failure. The device aims to improve heart function by creating a small passageway between the heart’s chambers to relieve pressure. Participants should have experienced symptoms of heart failure, such as frequent shortness of breath or fatigue, and required hospital visits or medication in the past year. This trial offers a chance to try an innovative treatment if standard therapies are insufficient. As an unphased trial, it provides a unique opportunity to explore cutting-edge treatment options that might not be available elsewhere.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it requires participants to be on stable guideline-directed medical therapy (GDMT) for heart failure. This suggests you may need to continue your current heart failure medications.

What prior data suggests that the Edwards APTURE transcatheter shunt system is safe?

Research has shown that the Edwards APTURE transcatheter shunt system has been tested for safety in people. Studies have found that this treatment is generally safe, meaning the shunt did not cause serious or unexpected health problems for most people. Specifically, previous patients experienced improvements in heart failure symptoms and overall quality of life without major negative effects.

The treatment also reduced a specific heart pressure measurement related to heart function, supporting the idea that the shunt can be safely used in patients with heart issues. Overall, evidence suggests that the Edwards APTURE shunt is generally well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Edwards Transcatheter Atrial Shunt System because it offers a novel, less invasive approach to managing heart failure. Unlike traditional treatments such as medications or surgical interventions, this system creates a small passageway between the atria of the heart using a catheter-based procedure. This can help reduce pressure on the heart and improve symptoms without requiring major surgery. Its unique delivery method allows for a quicker recovery time and potentially fewer complications, making it a promising option for patients with heart failure.

What evidence suggests that the Edwards APTURE transcatheter shunt system is effective for heart failure?

Research has shown that the Edwards Transcatheter Atrial Shunt System, which trial participants will receive, could benefit people with heart failure. Studies have found that it can improve heart failure symptoms and quality of life. The device lowers pressure in the heart, reducing stress on it. The ALT-FLOW trial found that the shunt system is safe and does not harm heart function. Overall, early evidence supports its potential effectiveness in managing heart failure. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure who've been hospitalized or needed urgent treatment in the past year. They should be on stable heart medication and able to attend follow-ups for 3 years. Participants must have certain levels of elevated pressure in their hearts, as measured by specific tests.

Inclusion Criteria

Pulmonary Vascular Resistance (PVR) < 5.0 WU as determined by site cardiologist

Left Ventricular Ejection Fraction (LVEF) ≤ 40% as determined by site cardiologist

Hemodynamic criteria: At rest - Elevated LAP (or PCWP) > 15 mmHg AND LAP > RAP + 5 mmHg AND/OR supine ergometer exercise: elevated LAP (or PCWP) > 25 mmHg AND LAP > RAP + 10 mmHg

Exclusion Criteria

Cardiac index ≤ 1.5 L/min/m2

Left Ventricular End-Diastolic Diameter (LVEDD) > 8 cm

LVEF <20%

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Edwards APTURE transcatheter shunt system and are monitored for initial clinical safety, device functionality, and effectiveness

10 days

In-hospital procedure and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in Qp/Qs, PCWP, PAP, RAP, PVR, and TAPSE

6 months

Regular follow-up visits at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Edwards Transcatheter Atrial Shunt System

Trial Overview The study is testing the APTURE transcatheter shunt system's safety and how well it works. It's an exploratory trial involving multiple centers where participants will receive this new device designed to help manage heart failure.

How Is the Trial Designed?

Group I: Edwards APTURE transcatheter shunt system Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Published Research Related to This Trial

Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis who are at moderate to high surgical risk, demonstrating significant efficacy in clinical trials.

Newer-generation devices, such as the SAPIEN-3 and CENTERA valves, have shown improvements in reducing paravalvular leaks and achieving excellent clinical outcomes, indicating advancements in TAVI technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Newer-generation of Edwards transcatheter aortic valve systems: SAPIEN 3, Centera, and SAPIEN 3 Ultra. Solomonica, A., Choudhury, T., Bagur, R.[2019]

Surgical aortic valve replacement (SAVR) significantly improves survival and quality of life in patients with severe aortic stenosis compared to medical therapy, as shown in the randomized PARTNER Trial.

Transcatheter Aortic Valve Replacement (TAVR) has been successfully performed on 56 patients at Rhode Island Hospital, yielding outcomes comparable to those in the PARTNER Trial, and is being explored for use in intermediate-risk patients with advancements in valve technology aimed at reducing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve replacement: a review of current indications and outcomes. Prabhu, W., Gordon, PC.[2014]

The Edwards SAPIEN transcatheter heart valve demonstrated a high success rate of 97.1% in deployment among 36 patients with moderate to severe pulmonary regurgitation, indicating its effectiveness in this patient population.

At 6-month follow-up, 97% of patients experienced significant improvements in their condition, with most showing reduced pulmonary regurgitation and a notable increase in functional status, suggesting the procedure is both safe and beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position: early phase 1 results from an international multicenter clinical trial. Kenny, D., Hijazi, ZM., Kar, S., et al.[2022]

The Edwards SAPIEN transcatheter heart valve (THV) is considered noninferior to traditional surgical aortic valve replacement for high-risk operable patients, based on the high-risk arm of the PARTNER trial.

Despite some concerns about safety and trial misconduct, the FDA panel unanimously agreed that the benefits of the Edwards SAPIEN THV outweigh the risks, leading to its approval for use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN transcatheter heart valve for high-risk aortic stenosis patients. Barbash, IM., Dvir, D., Waksman, R.[2013]

Citations

1. edwards.com edwards.com/healthcare-professionals/trial/altflow

ALT-FLOW trial A prospective, multicenter, randomized, double-blind, sham-controlled trial to assess the safety, performance, and effectiveness of the Edwards APTURE ...

2. jacc.org jacc.org/doi/10.1016/j.jchf.2025.02.003

The ALT-FLOW Trial (Early Feasibility Study) 2-Year Results The APTURE shunt confirmed an acceptable safety profile with improvements in HF symptoms, quality-of-life, and functional capacity without negatively affecting ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03523416

NCT03523416 | Early Feasibility Study - Edwards APTURE ... The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.

4. sciencedirect.com sciencedirect.com/science/article/pii/S193687982300571X

Left Atrial to Coronary Sinus Shunting for Treatment of ... The APTURE Transcatheter Shunt System in patients with symptomatic HF was observed to be safe and resulted in reduction in pulmonary capillary wedge pressure.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05686317

ALT-FLOW II Trial of the Edwards APTURE Transcatheter ... The objectives of this trial are to assess the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system when used for the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40019407/

The ALT-FLOW Trial (Early Feasibility Study) 2-Year Results Conclusions: In patients with HF and LVEF >40%, the APTURE shunt confirmed an acceptable safety profile with improvements in HF symptoms, quality of life, and ...