Transcatheter Shunt for Heart Failure

Recruiting at 2 trial locations

Overseen By Ana Gonzalez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

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

Trial Summary

What is the purpose of this trial?

The Exploratory study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system.

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 data supports the effectiveness of the treatment Edwards Transcatheter Atrial Shunt System for heart failure?

The Edwards SAPIEN transcatheter heart valve, a component of the Edwards Transcatheter Atrial Shunt System, has shown effectiveness in improving heart function in patients with severe aortic stenosis and pulmonary valve issues, suggesting potential benefits for heart failure treatment. ^{1 2 3 4 5}

Is the Edwards Transcatheter Atrial Shunt System generally safe for humans?

The Edwards SAPIEN transcatheter heart valve, a similar device, has been shown to be generally safe in humans, with some risks like stroke and vascular complications. It has been used successfully in high-risk patients with heart valve issues, suggesting a favorable safety profile. ^{1 3 6 7 8}

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

The Edwards Transcatheter Atrial Shunt System is unique because it involves creating a small passageway between the heart's upper chambers to help reduce pressure and improve symptoms in heart failure patients, unlike traditional treatments that often focus on medication or surgery to manage heart function. ^{1 3 5 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 (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]

References

1. 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]

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

Transcatheter aortic valve replacement: a review of current indications and outcomes. [2014]

3. United States 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. [2013]

4. Turkey pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve implantation with the Edwards Sapien 3 valve: First experiences in Turkey. [2018]

5. Poland pubmed.ncbi.nlm.nih.gov

[Transcatheter implantation of Edwards-SAPIEN THV valve in pulmonary position]. [2012]

6. England pubmed.ncbi.nlm.nih.gov

The Edwards SAPIEN Transcatheter Heart Valve for Calcific Aortic Stenosis: A Review of the Valve, Procedure, and Current Literature. [2021]

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

Percutanous management of tricuspid regurgitation: The "Achilles tendon" of transcatheter valve interventions. [2018]

8. Spain pubmed.ncbi.nlm.nih.gov

[Progress in transcatheter aortic valve implantation]. [2010]

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

Edwards SAPIEN XT in Native Stenotic Mitral Valve, Open Technique on Cardiopulmonary Bypass: An Option, But Safe? [2017]

10. England pubmed.ncbi.nlm.nih.gov

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