What side effects are associated with this type of intervention?

Common treatments for heart failure, particularly device-based therapies like the Edwards Transcatheter Atrial Shunt System, can have several side effects. These may include bleeding, infection, and device malfunction. Additionally, there can be complications related to the procedure itself, such as arrhythmias or thromboembolic events. General heart failure treatments, including medications like ACE inhibitors, beta-blockers, and diuretics, can cause side effects such as hypotension, electrolyte imbalances, renal dysfunction, and dizziness. It is important to discuss these potential risks with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for heart failure that involve structural interventions or pharmacological management. The MitraClip device, approved in 2013, is used for patients with severe mitral regurgitation who are not surgical candidates, functioning by clipping together portions of the mitral valve to reduce regurgitation. Additionally, medications like ACE inhibitors, beta-blockers, and diuretics are commonly used to manage heart failure by improving heart function and reducing fluid overload. While not directly analogous to the Edwards Transcatheter Atrial Shunt System, these treatments share the goal of improving cardiac efficiency and patient outcomes.

What other types of research exist?

Promising novel alternatives to the Edwards Transcatheter Atrial Shunt System for heart failure patients in 2024 include: 1) Baroreflex Activation Therapy (BAT) devices, which stimulate baroreceptors to reduce heart failure symptoms; 2) Cardiac Contractility Modulation (CCM) devices, which enhance the strength of heart contractions; and 3) MitraClip, a minimally invasive device for mitral valve repair that can improve heart function in heart failure patients with mitral regurgitation.

← Back to Search

Device

Transcatheter Atrial Shunt for Heart Failure (ALT-FLOW US Trial)

N/A

Waitlist Available

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic symptomatic Heart Failure (HF) documented by specific criteria

Successful reversibility of PH under a resting Sodium Nitroprusside* challenge (if baseline PVR is > 4.0, for Cohort B)

Must not have

Anatomy (including implantable devices) that is not compatible with the Edwards Transcatheter Atrial Shunt System

Propensity for increased Right ventricular dysfunction, defined by specific criteria (for Cohort B)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the insertion site, irregular heartbeat, bleeding or blood clots around the device area. There might also be risks associated with catheter-based procedures like infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with chronic heart failure.

Select...

My pulmonary hypertension improved with a specific test.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

My heart's right side is not working properly.

Select...

My kidneys are not working properly.

Select...

I cannot take certain blood thinners or have a bleeding disorder.

Select...

I am under legal guardianship.

Select...

I have had a stroke, TIA, or started cardiac therapy in the last 6 months.

Select...

I have not had unstable blood pressure or heart issues in the last 30 days.

Select...

I do not have severe heart failure.

Select...

I have been diagnosed with a specific type of heart muscle disease.

Select...

I can walk less than 50 meters or more than 600 meters in 6 minutes.

Select...

My heart's right side is not working properly.

Select...

My liver is not working well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)

Secondary study objectives

Change in Pulmonary Vascular Resistance (PVR) from Baseline to Follow Up

Change in mean systolic & diastolic pulmonary artery pressure (PAP) and change in mean right atrial pressure (RAP) from Baseline to Follow Up

Change in pulmonary capillary wedge pressure (PCWP) from Baseline to Follow Up

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Edwards Transcatheter Atrial Shunt SystemExperimental Treatment1 Intervention

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart failure include medications like beta-blockers, ACE inhibitors, and diuretics, which work by reducing the heart's workload, lowering blood pressure, and removing excess fluid, respectively. Additionally, device therapies such as cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillators (ICDs) help improve heart function and prevent sudden cardiac death. The Edwards Transcatheter Atrial Shunt System, which creates a controlled shunt between the atria, aims to reduce pressure in the left atrium and improve symptoms. This matters for heart failure patients as it can alleviate symptoms, improve quality of life, and potentially reduce hospitalizations by addressing the underlying hemodynamic imbalances.

Role of Echocardiography for Assessment of Cardiac Remodeling in Congenitally Corrected Transposition of Great Arteries.