Transcatheter Atrial Shunt for Heart Failure

(ALT-FLOW US Trial)

Recruiting at 17 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

71 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new device to help patients with heart problems by creating a small passageway between the upper chambers of their heart. This can make it easier for blood to flow and reduce the heart's workload. Since the initial description of a device for heart issues in the mid-1970s by King and Mills, a number of devices have been developed.

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

The Edwards SAPIEN transcatheter heart valve, a component of the Edwards Transcatheter Atrial Shunt System, has shown effectiveness in treating heart valve issues like aortic stenosis and pulmonary regurgitation, suggesting potential benefits for heart failure patients. It has been approved by the FDA for high-risk patients, indicating its safety and effectiveness in similar heart conditions. ^{1 2 3 4 5}

Is the Transcatheter Atrial Shunt safe for humans?

Research shows that the Transcatheter Atrial Shunt, also known as the interatrial shunt device, has been successfully implanted in patients with heart failure without causing adverse events, indicating it is generally safe in humans. ^{6 7 8 9 10}

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 reduce pressure and improve symptoms in heart failure patients, unlike traditional treatments that primarily focus on medication or surgical interventions. ^{1 3 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

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]

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]

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]

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]

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

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

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

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

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

Long-term follow-up of a patient undergoing interatrial shunt device implantation for treatment of heart failure with a preserved ejection fraction. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Unidirectional left-to-right interatrial shunting for treatment of patients with heart failure with reduced ejection fraction: a safety and proof-of-principle cohort study. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Haemodynamic changes of interatrial shunting devices for heart failure: a systematic review and meta-analysis. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Impact of atrial flow regulator (AFR) implantation on 12-month mortality in heart failure : Insights from a single site in the PRELIEVE study. [2022]

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

Blood pressure and adverse events during continuous flow left ventricular assist device support. [2015]

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

Successful implantation of the Edwards Sapien THV via direct aortic access in a patient with previous pneumonectomy and no other access. [2016]

12. England pubmed.ncbi.nlm.nih.gov

A Left-to-Right Shunt After Transfemoral TAVR Using Edwards SAPIEN 3. [2018]

13. England pubmed.ncbi.nlm.nih.gov

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