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Inter-Atrial Shunt Device

Inter-Atrial Shunt Device for Heart Failure

N/A

Waitlist Available

Led By Sanjiv Shah, MD

Research Sponsored by Corvia Medical

Eligibility Criteria Checklist

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

Must have

Age ≥ 40 years old

Chronic symptomatic Heart Failure

Must not have

Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation

MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month post implant

Summary

This trial is testing a device to see if it can help reduce pressure in the left atrium for people with heart failure.

Who is the study for?

This trial is for adults over 40 with chronic heart failure who have a left ventricular ejection fraction of at least 40% and elevated left atrial pressure. They must be on stable heart failure medication, able to do some exercise but not too much (can walk between 50m and 600m in six minutes), and their kidneys must work well enough (estimated-GFR ≥25ml/min/1.73 m2). People with severe heart failure, recent heart attacks or surgeries, significant untreated artery blockages, serious valve disease, or recent strokes aren't eligible.

What is being tested?

The study tests the IASD System II device designed by Corvia Medical to lower high pressure in the left atrium of the heart in patients with Heart Failure. It also uses Intracardiac Echo as part of the procedure to help doctors see inside the heart better during treatment.

What are the potential side effects?

Potential side effects may include complications from placing the device like bleeding or infection, irregular heartbeat due to irritation inside the heart where the device sits, blood clots that could lead to stroke if they travel through holes made by the shunt device.

Eligibility Criteria

Inclusion Criteria

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

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I am 40 years old or older.

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I have ongoing heart failure symptoms.

Exclusion Criteria

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

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I am on dialysis or my kidney function is very low.

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I have had a heart attack or heart surgery in the last 3 months.

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I have severe heart failure.

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I cannot walk 50m in 6 minutes, or I can walk more than 600m.

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I have a significant blockage in my neck artery that hasn't been treated.

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I have a serious heart valve problem.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month post implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month post implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month post implant for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in supine exercise pulmonary capillary wedge pressure (PCWP)

Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment with Inter-Atrial Shunt DeviceExperimental Treatment1 Intervention

Once all study criteria have been met, if randomized to this arm, patients will receive the IASD implant.

Group II: ControlPlacebo Group1 Intervention

Once all study criteria have been met, if randomized to this arm, patients will not receive the implant. They will undergo an intracardiac echo only, with the option to crossover at 1 year.

0 / 8Eligibility criteria met