Transcatheter Atrial Shunt for Heart Failure

(ALT-FLOW US Trial)

Not currently recruiting at 18 trial locations

Overseen By Natalie Alon

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Must be taking: Guideline directed therapy

Disqualifiers: Severe heart failure, Valve disease, Dialysis, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Edwards Transcatheter Atrial Shunt System, to determine its safety and effectiveness for people with heart failure. The device manages symptoms by improving the heart's blood flow. Suitable candidates have heart failure symptoms that disrupt daily life, such as frequent hospital visits or regular medication needs. The trial aims to offer a new option for those who haven't found relief from standard treatments. As an unphased trial, it provides patients the chance to explore innovative treatments that may enhance their quality of life.

Will I have to stop taking my current medications?

The trial requires participants to be on stable Guideline Directed Medical Therapy (GDMT) for heart failure, so you should continue your current heart failure medications.

What prior data suggests that the Edwards Transcatheter Atrial Shunt System is safe for heart failure patients?

Research has shown that the Edwards Transcatheter Atrial Shunt System is generally safe. In earlier studies, patients with heart failure (when the heart can't pump enough blood) used this shunt and experienced positive results. They had fewer symptoms, felt better overall, and could engage in more physical activities. Importantly, no serious side effects occurred, indicating good safety.

The ALT-FLOW trial, which closely examined this shunt, also found it safe for patients. It helped lower pressure in the heart, an important factor in treating heart failure. Overall, the evidence suggests that patients generally tolerate the shunt well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Edwards Transcatheter Atrial Shunt System is unique because it offers a novel approach to managing heart failure. Unlike traditional treatments, which typically rely on medications like diuretics or ACE inhibitors to alleviate symptoms, this system uses a small device to create a shunt between the heart's atria. This innovative method helps reduce pressure on the heart by allowing excess blood to bypass the overworked ventricles. Researchers are excited about this treatment because it has the potential to improve symptoms and quality of life for patients with heart failure by directly addressing the heart's structural issues without the need for invasive surgery.

What evidence suggests that the Edwards Transcatheter Atrial Shunt System is effective for heart failure?

Research has shown that the Edwards Transcatheter Atrial Shunt System, which participants in this trial will receive, may help treat heart failure. In studies, patients using this shunt experienced better heart failure symptoms and improved quality of life. The system also safely reduced pressure on the left side of the heart, an important factor in managing heart failure. These early findings are promising and suggest that the shunt could be a helpful new option for heart failure patients. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic heart failure who are on stable heart medication and can attend follow-ups for up to 5 years. It's not for those with severe heart issues, valve diseases, certain cardiomyopathies, renal insufficiency, metal allergies, or life expectancy less than a year due to non-heart conditions.

Inclusion Criteria

I have been diagnosed with chronic heart failure.

Willing to attend study follow-up assessments for up to 5 years

I am on a stable treatment plan for heart failure.

Exclusion Criteria

My heart has significant valve issues, confirmed by a cardiologist.

My body or any device in it is not suitable for the Edwards heart shunt system.

You are currently using recreational drugs through injection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the implantation of the Edwards Transcatheter Atrial Shunt System

1 day

1 visit (in-person)

Post-Procedure Monitoring

Participants are monitored for device success and safety, including shunt patency and discharge without additional intervention

10 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for changes in hemodynamic parameters and device effectiveness

6 months

Regular visits (in-person) at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Edwards Transcatheter Atrial Shunt System

Trial Overview The study tests the Edwards Transcatheter Atrial Shunt System's safety and effectiveness in patients with heart failure. The device aims to relieve symptoms by creating a small passage between the left and right atria of the heart.

How Is the Trial Designed?

Group I: Edwards Transcatheter Atrial 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

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]

In a study of patients supported by continuous flow left ventricular assist devices for 30 days to 18 months, higher Doppler blood pressure (DOPBP) levels were linked to a greater risk of adverse events (AEs) such as intracranial hemorrhage and progressive aortic insufficiency.

Patients with high DOPBP (>90 mm Hg) experienced AEs at a rate of 30%, compared to 13% in the intermediate group (80-90 mm Hg) and only 3% in the controlled group (<80 mm Hg), indicating that better blood pressure control may reduce the risk of serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood pressure and adverse events during continuous flow left ventricular assist device support. Saeed, O., Jermyn, R., Kargoli, F., et al.[2015]

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]

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]

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 ...