Active not recruitingNAINTERVENTIONAL

REDUCE LAP-HF TRIAL II

This research study, called REDUCE LAP-HF TRIAL II, is investigating a small device (IASD System II) for people living with heart failure. Heart failure means your heart can't pump blood as well as it should, leading to symptoms like breathlessness. The study wants to find out if putting this device into the heart can help reduce symptoms and improve how people feel. Participants are randomly put into two groups: one group receives the implant, and the other group has a procedure that checks their heart without putting in the device. This helps researchers compare the effects accurately. The study will follow people for five years to understand the long-term benefits.

At a glance

Status

Active not recruiting

Phase

Sponsor

Corvia Medical

Enrolment target

608

Start

01 Jun 2017

Estimated completion

01 Sep 2026

Heart Failure

What is this study about?

This study is designed for individuals who have heart failure. Heart failure is a condition where your heart struggles to pump enough blood around your body. This can lead to symptoms such as feeling very tired, short of breath, or having swollen ankles. The purpose of this study is to test a new, small device called the IASD System II, which is designed to be implanted in your heart.

The researchers want to see if this implant can help reduce the pressure buildup in the left side of your heart, which is a common problem in heart failure. By potentially lowering this pressure, the hope is that it could make you feel better and improve your quality of life. The study uses a careful method to ensure reliable results: participants are randomly assigned to either receive the implant or have a similar procedure without the implant. This fair comparison helps scientists understand if the device truly makes a difference.

All participants will be closely monitored for five years. This long follow-up period allows the researchers to gather important information about how the device works over time, its safety, and whether it leads to lasting improvements for people with heart failure. The information gained from this study could help improve future treatments for heart failure patients.

Key takeaways

This study is testing a new heart device for heart failure.
It aims to reduce symptoms and improve quality of life.
A special exercise test determines eligibility.
Participants are randomly assigned to get the device or not.
You'll be followed for 5 years, with close monitoring.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to be at least 40 years old and have ongoing symptoms of heart failure that require medication, particularly diuretics. Your heart failure should have led to symptoms like shortness of breath during daily activities or possibly a hospital stay for heart failure in the past year. Also, your heart's pumping ability (ejection fraction) should be at least 40%.

There are also specific measurements related to the pressure inside your heart during exercise that need to meet certain levels. This is checked with a special test where you exercise on a bicycle while lying down. Your heart failure medication should be stable for at least a month before starting the study.

Some things would prevent you from joining. For example, if you've had a heart attack or certain heart procedures in the last few months, or if you have very severe or advanced heart failure. If you've recently had a pacemaker or similar device fitted to help your heart beat in a coordinated way, that would also disqualify you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 40 years old?
Do you have ongoing symptoms of heart failure?
Do you take diuretics for your heart failure?
Has your heart failure caused serious symptoms or a hospital visit in the past year?
Is your heart's pumping strength (ejection fraction) at least 40%?
Have your heart failure medications been stable for at least one month?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first undergo a special exercise test on a bicycle while lying down to confirm you meet the study's requirements. If you're eligible, you'll be randomly assigned to one of two groups. Both groups will have a small tube (sheath) placed in a vein in your groin after receiving a mild sedative to help you relax.

If you're in the 'treatment' group, doctors will use imaging guidance (like an internal ultrasound or an ultrasound through the food pipe) to pinpoint the right spot in your heart. They will then create a tiny opening and implant the IASD System II device. If you're in the 'control' group, you'll undergo a similar procedure where doctors examine your heart's structure using the same imaging tools, but without implanting the device. This helps compare the two groups fairly.

You will have several follow-up appointments over the next five years to check on your health and how you're feeling. For the first two years, neither you nor your doctors will know which group you're in (unless it's medically necessary), but after the 24-month visit, everyone will find out.

Potential risks and benefits

Taking part in this study could potentially offer a new treatment option for your heart failure. However, as with any medical procedure, there are potential risks, such as bleeding, infection, or problems related to the implant. Being in the control group means you will have a procedure without receiving the new device, but you will still be closely monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (91)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Arizona Cardiovascular Research Center
Verified postcode
Phoenix, United States
University of Arizona College of Medicine
Verified postcode
Tucson, United States
Scripps Clinic
Verified postcode
La Jolla, United States
Kaiser Permanente San Diego
Verified postcode
La Jolla, United States
Kaiser Permanente San Francisco Medical Center
Verified postcode
San Francisco, United States
South Denver Cardiology Associates
Verified postcode
Littleton, United States
Yale University
Verified postcode
New Haven, United States
Medstar Washington Hospital Center
Verified postcode
Washington D.C., United States
Holy Cross Hospital
Verified postcode
Fort Lauderdale, United States
Sarasota Memorial Hospital
Verified postcode
Sarasota, United States
Tallahassee Research Institute, Inc.
Verified postcode
Tallahassee, United States
Cleveland Clinic Florida
Verified postcode
Weston, United States

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood as effectively as it should, leading to symptoms like tiredness, shortness of breath, and swelling. It doesn't mean your heart has stopped working.

What is the IASD System II?

It's a small device that doctors might implant in your heart. The aim is to help balance the pressures inside your heart, which could reduce your heart failure symptoms.

Will I know if I get the new device?

For the first two years of the study, you and your doctors will not know if you received the device or not. This is to ensure the results are fair. After two years, everyone will find out.

How long will I be in the study?

You will be followed by the study team for a total of five years to see how you are doing over the long term.

Can I leave the study at any time?

Yes, absolutely. You can decide to leave the study at any point, and your decision will not affect your regular medical care.