Active not recruitingNAINTERVENTIONAL

Portico Next Generation Approval Study

This study is looking at a new heart valve, called Portico™ NG, for people who have a serious condition called severe aortic stenosis. This means their heart's main valve doesn't open properly, making their heart work much harder. We're studying patients who are very unwell or have other health problems that make standard surgery risky. The main goal is to check if this new valve is safe and effective within the first 30 days after it's put in. We also want to know if it helps with blood leaking around the new valve. This research is important to help the new valve become widely available for patients who need it.

At a glance

Status

Active not recruiting

Phase

Sponsor

Abbott Medical Devices

Enrolment target

333

Start

17 Sep 2019

Estimated completion

01 Dec 2027

Symptomatic Severe Aortic Stenosis

Results

Results from this study

Posted July 2024

Results have been published for this study.

Primary outcome

Primary Safety Endpoint is All-cause Mortality

All-cause mortality is defined as the total number of deaths in each cohort at 30 days.

Full results on the registry

What is this study about?

This clinical study is evaluating a new type of heart valve replacement called the Portico™ NG Transcatheter Aortic Heart Valve. It's designed for patients with a condition called severe aortic stenosis. This is where the main valve in your heart (the aortic valve) becomes stiff and narrowed, making it hard for blood to flow out to the rest of your body. This can cause symptoms like chest pain, breathlessness, and dizziness.

The new valve is put in using a less invasive procedure, meaning doctors don't have to open up your chest as much as with traditional surgery. This study is specifically for people who are considered to be at high or extreme risk for open-heart surgery, often because they have other serious health issues or are very unwell. The information gathered from this study will help determine if the Portico™ NG valve is safe and works well enough to be approved for use by medical authorities in Europe and the United States.

Researchers will be looking closely at how patients recover after getting the new valve, focusing on things like overall health within 30 days and if there's any leaking around the new valve. They are also testing a slightly larger version of the valve, called the Navitor Titan™ valve, for some patients. The aim is to make sure these new options are good and safe ways to treat severe aortic stenosis for people who really need them.

Key takeaways

Tests a new heart valve (Portico™ NG) for severe aortic stenosis.
Aims for patients at high risk for traditional heart surgery.
Evaluates safety and how well the valve works.
Involves a less invasive procedure to implant the valve.
Requires follow-up appointments for up to five years.
Information helps the valve get approved for wider use.

Who may be eligible?

This study is for adults generally aged between 18 and 100 years old. You might be suitable if you have severe aortic stenosis and symptoms like breathlessness or chest pain, and your doctors believe you are at high risk for traditional open-heart surgery. This 'high risk' could be due to your age, general health, or other medical problems.

To join, your aortic valve opening would need to be very narrow based on scans, and your heart valve measurements must fall within a specific range for the new valve to fit properly.

You would not be able to join if you've recently had a heart attack, a stroke, or certain blood disorders, or if you have an active stomach ulcer. If you've had other heart procedures recently or if you have a different type of heart valve problem that is more serious than your aortic stenosis, you would also not be able to take part.

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.

Do I have severe aortic stenosis?
Am I considered at high or extreme risk for open-heart surgery?
Do I have symptoms like shortness of breath or chest pain?
Have I had a heart attack or stroke in the last 6 months?
Am I generally between 18 and 100 years old?
Do I have any problems with blood clotting or active stomach ulcers?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through a screening process to check if you meet all the requirements. This involves various tests and scans. If you are eligible, you will have the new heart valve fitted. This procedure usually involves placing the valve through a small cut in your leg or another access point.

After the procedure, doctors will monitor you closely in the hospital until you are ready to go home. You will then have follow-up appointments at 30 days and 12 months after your procedure. Following that, you'll have annual check-ups for up to five years. These appointments will involve various assessments to see how you are recovering and how well the new valve is working. You won't be given any experimental medication, but your doctors will manage your care and regular medication as usual.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit could be access to a new heart valve that might improve your heart condition, especially if traditional surgery is too risky for you. However, there are also risks associated with any medical procedure, including infection, bleeding, or problems with the valve. The study is designed to carefully monitor your health throughout. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (28)

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

Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States
Los Robles Regional Medical Center
Verified postcode
Thousand Oaks, United States
Washington Hospital Center
Verified postcode
Washington D.C., United States
Advocate Christ Medical Center
Verified postcode
Oak Lawn, United States
St. Vincent Hospital
Verified postcode
Indianapolis, United States
Via Christi Regional Medical Center
Verified postcode
Wichita, United States
Sparrow Clinical Research Institute
Verified postcode
Lansing, United States
Minneapolis Heart Institute
Verified postcode
Minneapolis, United States
Atlantic Health System - Morristown Memorial Hospital
Verified postcode
Morristown, United States
Albany Medical Center
Verified postcode
Albany, United States
Columbia University Medical Center/NYPH
Verified postcode
New York, United States
Montefiore Medical Center - Moses Division
Verified postcode
New York, United States

Common questions

What is severe aortic stenosis?

It's when the main valve in your heart narrows and stiffens, making it hard for blood to pump out, leading to symptoms like shortness of breath or chest pain.

What does 'high surgical risk' mean?

It means that having traditional open-heart surgery would be riskier for you due to your age, other health problems, or frailty.

Is this a new type of heart valve?

Yes, the study is testing a newer version of a replacement heart valve called Portico™ NG, which is put in using a less invasive method.

How long will I be followed in the study?

After the valve is fitted, you'll have follow-up appointments over five years to check on your health and the valve's performance.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any point without it affecting your medical care.