Active not recruitingNAINTERVENTIONAL

ASCEND CSP IDE Study

This important study is looking into a new way to help people with heart failure who also have dangerous irregular heartbeats. It's called the ASCEND CSP IDE Study. Researchers are testing a special wire, known as the CSP ICD Lead, that works with heart devices like ICDs or CRT-Ds. These devices can help correct heart rhythm problems and improve how well the heart pumps blood. The study wants to see how safe this new lead is and how well it works in real-world settings. It involves many patients across different countries to get a good understanding of its benefits and any potential downsides, aiming to improve future treatments for heart conditions.

At a glance

Status

Active not recruiting

Phase

Sponsor

Abbott Medical Devices

Enrolment target

414

Start

11 Apr 2025

Estimated completion

01 May 2028

Heart Failure Ventricular Arrythmia

What is this study about?

You might be reading this because you, or someone you know, has heart failure. Heart failure means your heart isn't pumping blood as well as it should. Sometimes, this can lead to irregular heartbeats, which can be very serious. To help with this, doctors sometimes recommend special devices like ICDs (Implantable Cardioverter-Defibrillators) or CRT-Ds (Cardiac Resynchronization Therapy Defibrillators). These devices are like tiny computers that are implanted under your skin and connected to your heart with special wires called leads. They can monitor your heart rhythm and deliver small electrical pulses to keep it regular or even give a stronger shock if needed to correct a dangerous rhythm.

This particular study, called the ASCEND CSP IDE Study, is focusing on a new type of these wires – specifically, a "CSP ICD Lead." The idea behind this new lead is to make the heart devices work even better by placing the lead in a very precise spot inside your heart. This study is designed to carefully check if this new CSP ICD Lead is safe for patients and if it works effectively to manage heart problems. If it proves to be safe and helpful, it could mean better treatment options for people with heart failure and irregular heartbeats in the future.

The study is taking place in many different hospitals around the world and will involve a significant number of patients. This large scale helps researchers gather a lot of information to make sure the findings are reliable. The ultimate goal is to improve how we treat these serious heart conditions and help people live healthier lives.

Key takeaways

This study is testing a new heart device wire called the CSP ICD Lead.
It's for adults with heart failure who need a new ICD or CRT-D device.
The goal is to see if the new lead is safe and works well to control irregular heartbeats.
Participation involves having the new lead implanted and attending regular follow-up appointments.
It's a global study, aiming to improve future treatments for heart conditions.

Who may be eligible?

To join this study, you generally need to be an adult (18 or older) who has been advised by your doctor to have a new ICD or CRT-D device implanted. Your doctor will make sure that the type of heart device you need is one that is being studied with this new special wire, the CSP ICD Lead.

There are also some reasons why you might not be able to join. For example, if you've had a heart attack, certain heart procedures, or a stroke very recently (within the last few months), or if your doctor thinks your life expectancy is less than a year, you likely wouldn't be able to take part. Also, if there are medical reasons that make it unsafe to place the study's special lead, you wouldn't be eligible.

Most importantly, you need to be willing to come to all your follow-up appointments and agree to the study plan. You will also need to read and sign an informed consent form, which means you understand what the study involves and are happy to participate.

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 18 years old or older?
Has your doctor recommended you have a new ICD or CRT-D device implanted?
Are you willing to attend regular follow-up appointments at the clinic?
Have you not had a recent heart attack, stroke, or major heart procedure in the last few months?
Do you expect to live for more than 12 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll have a new heart device, along with the special CSP ICD Lead, implanted. After the procedure, you'll have regular check-ups at the clinic. These visits are important for the medical team to monitor your heart device, make sure the lead is working correctly, and check on your overall health. These appointments will involve tests and exams, similar to what you might have with a standard heart device. The study will likely involve several follow-up visits over a period of time, but the exact duration for each patient isn't specified here. You'll be told about the exact schedule of visits and what each will involve before you agree to join.

Potential risks and benefits

Taking part in this study means you'd be receiving a new therapy that might improve how your heart device works, potentially leading to better control of irregular heartbeats and improved quality of life. However, like any medical procedure, there are potential risks, such as those associated with implanting a heart device and leads, including infection, bleeding, or issues with the lead itself. The research team will carefully monitor participants for any problems. Remember, joining any study is completely voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (37)

Heart Center Research LLC
Verified postcode
Huntsville, United States
Banner University Medical Center Phoenix
Verified postcode
Phoenix, United States
Arrhythmia Research Group
Verified postcode
Jonesboro, United States
Premier Cardiology, Inc.
Verified postcode
Newport Beach, United States
University of California at San Diego (UCSD) Medical Center
Verified postcode
San Diego, United States
MedStar Washington Hospital Center
Verified postcode
Washington D.C., United States
AdventHealth Orlando
Verified postcode
Orlando, United States
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States
New York Presbyterian Hospital/Cornell University
Verified postcode
New York, United States
The Cleveland Clinic Foundation
Verified postcode
Cleveland, United States
Geisinger Medical Center
Verified postcode
Danville, United States
Lancaster General Hospital
Verified postcode
Lancaster, United States

Common questions

What is an ICD or CRT-D device?

These are small, implantable devices that help manage serious heart rhythm problems. An ICD can deliver a shock to correct a fast, dangerous heartbeat, while a CRT-D also helps the heart's chambers beat in a more coordinated way.

What is a 'lead'?

A lead is a thin, insulated wire that connects your heart device to your heart. It carries electrical signals from the heart to the device and delivers electrical pulses or shocks back to the heart.

What is the 'CSP ICD Lead' and how is it different?

The CSP ICD Lead is a new type of wire being tested. Its design is intended to allow for more precise placement in the heart, which doctors hope will make the heart device work more effectively for some patients.

Will I know if I'm getting the old or new lead?

If you join this study, you will specifically receive the new 'CSP ICD Lead' along with your heart device. This study is focused on how well this new lead works.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your future medical care.