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Atrial Shunt

Transcatheter Shunt for Heart Failure

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
Symptomatic HF: NYHA II w/ history of > II; III; or ambulatory IV AND ≥1 HF hospitalization OR treatment with IV or oral diuresis within 12 months OR Elevated NT-proBNP value > 150 pg/ml in normal sinus rhythm, >450 pg/ml in atrial fibrillation, OR a BNP value > 50 pg/ml in normal sinus rhythm, > 150 pg/ml in atrial fibrillation within the past 6 months prior to study entry
Be older than 18 years old
Must not have
RV dysfunction > mild by TTE OR TAPSE <1.2 OR RV size ≥ LV size by TTE, OR Right Ventricular Fractional Area Change (RVFAC) ≤ 25%
6MWT <50m OR >400m
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 people with heart failure. The device is placed in the heart and helps to redirect blood flow. The trial will evaluate the safety and effectiveness of the device.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not detailed here but may include complications related to device implantation, such as bleeding or infection, and any impact on heart function due to changes in blood flow caused by the shunt.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have heart failure symptoms and have been hospitalized or needed strong water pills recently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart's right ventricle is not functioning well.
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I can walk less than 50 meters or more than 400 meters in 6 minutes.
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I have not had a stroke, TIA, or a CRT device implanted in the last 6 months.
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I have severe heart failure and cannot walk or am waiting for a heart transplant.
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I have severe valve disease.
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I have not had a heart attack or heart procedure in the last 3 months.
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I am on dialysis or have kidney problems with specific test results.

Timeline

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 APTURE transcatheter shunt systemExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
63,063 Total Patients Enrolled
14 Trials studying Heart Failure
3,192 Patients Enrolled for Heart Failure
~7 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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