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Device

IASD System II Implant 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

NYHA class II with a history of > NYHA class II; OR NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months;

Chronic symptomatic Heart Failure (HF) documented by one or more of the following:

Must not have

Known clinically significant untreated carotid artery stenosis likely to require intervention

MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Summary

This trial is testing whether a new medical device is effective and safe.

Who is the study for?

This trial is for adults over 40 with chronic heart failure, who have symptoms like shortness of breath or a history of hospital visits for heart failure. They should have a left ventricular ejection fraction of 40% or higher and be on stable heart failure medication. People can't join if they need dialysis, had recent major heart procedures, or have severe valve disease.

What is being tested?

The REDUCE LAP-HF TRIAL II is testing the IASD System II implant against standard care in people with heart failure. Participants are randomly assigned to either get the implant or not in equal numbers, and neither the participants nor the study team will know who got which treatment (blinded).

What are the potential side effects?

Possible side effects from the IASD System II implant may include complications related to the procedure such as bleeding or infection, issues with device placement, and potential impact on heart function.

Eligibility Criteria

Inclusion Criteria

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

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I have moderate to severe heart failure symptoms or signs in the past year.

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I have chronic heart failure with symptoms.

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I am 40 or older with a heart function (EF) of 40% or more in the last 3 months, and never had EF below 30% in the past 3 years.

Exclusion Criteria

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

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I have a serious untreated blockage in my neck artery that may need treatment.

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I have had a heart attack, heart surgery, or a procedure to open my heart's arteries in the last 3-12 months.

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I have advanced heart failure.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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

Composite Primary Endpoint

Secondary study objectives

Change in Kansas City Cardiomyopathy Questionnaire

Change in NYHA Class

Composite safety endpoint defined as follows

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II implant procedure.

Group II: ControlPlacebo Group1 Intervention

Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.

0 / 7Eligibility criteria met