Transcatheter Shunt System for Heart Failure

(ALT-FLOW II Trial)

Recruiting at 27 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

Trial Summary

What is the purpose of this trial?

This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.

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.

How is the Edwards APTURE Transcatheter Shunt System treatment different from other heart failure treatments?

The Edwards APTURE Transcatheter Shunt System is unique because it involves a minimally invasive procedure to create a shunt (a small passage) in the heart, which can help reduce pressure and improve symptoms in heart failure patients. This approach is different from traditional heart failure treatments that often rely on medications or more invasive surgeries. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

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]

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]

References

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

Edwards SAPIEN Transcatheter Pulmonary Valve Implantation: Results From a French Registry. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Newer-generation of Edwards transcatheter aortic valve systems: SAPIEN 3, Centera, and SAPIEN 3 Ultra. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Transthoracic access for transcatheter aortic valve replacement: technique using the Edwards Sapien Retroflex delivery system. [2014]

4. United States 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. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

First successful trans-catheter aortic valve implantation through ascending aorta using Edwards SAPIEN THV system. [2016]