Transcatheter Shunt System for Heart Failure

(ALT-FLOW II Trial)

Recruiting at 32 trial locations

Overseen By Thomas Cimato, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Must be taking: GDMT for HFpEF/HFmrEF

Disqualifiers: Severe heart failure, Valve disease, RV dysfunction, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Edwards APTURE Transcatheter Shunt System, for individuals with heart failure, specifically HFmrEF or HFpEF, which involve preserved or mildly reduced ejection fraction. The researchers aim to determine if this device can improve symptoms compared to a sham procedure. Participants must have experienced heart failure symptoms and treatments, such as hospital visits or medication adjustments, within the past year. This trial excludes those with severe heart failure or recent heart attacks. As an unphased trial, it offers participants the chance to contribute to pioneering research that could lead to new treatment options for heart failure.

Will I have to stop taking my current medications?

The trial requires that participants stay on their current heart failure medications without change for 6 months before joining the study.

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

Research shows that the Edwards APTURE Transcatheter Shunt System is safe for people. Studies have found that this device improves heart failure symptoms and enhances quality of life. Importantly, these benefits occur without serious side effects. Another study found that the shunt helped lower pressure in the heart, benefiting those with heart failure. Overall, evidence suggests that the treatment is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Edwards APTURE Transcatheter Shunt System is unique because it offers a new, minimally invasive approach to treating heart failure. Unlike conventional treatments that primarily rely on medications like ACE inhibitors, beta-blockers, and diuretics to manage symptoms, this device creates a small, controlled shunt between the left and right atria of the heart. This innovative mechanism allows for improved cardiac efficiency by reducing pressure on the heart and enhancing blood flow. Researchers are excited about this treatment because it has the potential to provide significant symptom relief and improve quality of life for patients who might not respond well to standard drug therapies.

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

Research shows that the Edwards APTURE Transcatheter Shunt System may help treat heart failure symptoms. In the ALT-FLOW trial, patients using the APTURE shunt experienced fewer heart failure symptoms, improved quality of life, and increased ease of exercise. The treatment proved generally safe for patients. Additionally, the shunt reduced fluid pressure in the lungs, which is important for heart health. In this trial, participants will receive either the APTURE shunt with medical therapy or a sham procedure with medical therapy. These findings suggest that the APTURE shunt could be a good option for managing heart failure. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with heart failure who have been on stable heart medication for over a month, experienced at least one hospitalization due to heart failure in the past year, and show specific signs of lung congestion during exercise. They must not have severe kidney issues, recent strokes or infections, certain types of valve disease, very poor walking ability or extremely severe heart failure.

Inclusion Criteria

My heart's pumping ability is reduced but not severely, and I have moderate to severe difficulty with physical activity.

I have heart failure that causes me symptoms.

I have been hospitalized for heart failure or have high BNP/NT-proBNP levels.

Exclusion Criteria

I haven't had a heart attack or heart procedure in the last 3 months.

I have not had heart medication through an IV in the last 6 months.

I was diagnosed with heart failure where my heart was not pumping well, but it has since improved.

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 or a sham procedure along with medical therapy

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments like KCCQ-OSS and 6MWT

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Edwards APTURE Transcatheter Shunt System

Trial Overview The ALT-FLOW II Trial is testing the Edwards APTURE transcatheter shunt system against a sham procedure (a fake operation that seems real) to see if it helps patients with heart failure. Participants are randomly chosen to receive either the actual device implantation or a pretend procedure without receiving the device.

How Is the Trial Designed?

Group I: APTURE shunt + medical therapy Experimental Treatment 1 Intervention

Group II: Sham + medical therapy Placebo Group 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

Trans-catheter aortic valve implantation (TAVI) is becoming a standard treatment for high-risk patients with critical aortic stenosis, offering a less invasive alternative to traditional surgery.

In a specific case where standard trans-catheter methods were not feasible, successful valve implantation was achieved through a novel trans-aortic approach, highlighting the adaptability and potential of TAVI techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First successful trans-catheter aortic valve implantation through ascending aorta using Edwards SAPIEN THV system. Bapat, V., Thomas, M., Hancock, J., et al.[2016]

The Edwards Sapien transfemoral Retroflex 3 catheter delivery system is effective for transcatheter aortic valve replacement using both transapical and transaortic approaches.

This delivery system offers several advantages over other devices, indicating its potential for improved safety and efficacy in valve replacement procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transthoracic access for transcatheter aortic valve replacement: technique using the Edwards Sapien Retroflex delivery system. George, I., Kriegel, J., Nazif, T., et al.[2014]

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]

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 was successfully implanted in 95.8% of the 71 patients treated for pulmonary valve issues, indicating a high procedural success rate.

Early complications were relatively low at 5.6%, with no significant regurgitation post-procedure and a significant reduction in transpulmonary gradient, suggesting effective valve function and safety in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Edwards SAPIEN Transcatheter Pulmonary Valve Implantation: Results From a French Registry. Plessis, J., Hascoët, S., Baruteau, A., et al.[2019]

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/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 ...

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/NCT03523416

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

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 ...