VASC-AF Study: Vascular Closure vs Manual Compression
This study, called VASC-AF, focuses on people having a common heart procedure for a condition called Atrial Fibrillation (AF), which causes an irregular heartbeat. After this procedure, a small cut (access site) needs to be closed. Doctors usually use firm pressure (manual compression) or stitches. This study is testing a new device called VASCADE MVP against these older methods. The main goal is to find out if the device helps people get up and walk around sooner after their procedure. Researchers will also check if the device is safe and effective in preventing complications. Half the participants will receive the new device, and the other half will have the traditional care. They'll be followed up through hospital discharge and a phone call 30 days later.
At a glance
What is this study about?
Heart conditions like Atrial Fibrillation (AF) can make your heartbeat irregular. To help with this, doctors sometimes perform a procedure called a PVI. After this procedure, a small opening in your skin is made to access blood vessels. This opening then needs to be closed to stop any bleeding. Traditionally, doctors use firm pressure, called manual compression, or a stitch to close this opening. This can sometimes mean you need to lie still for a while after the procedure.
This study, called VASC-AF, is looking at a new device called VASCADE MVP. This device is designed to close the opening quickly and effectively. The main reason for this study is to see if using this device helps people get up and walk around sooner after their heart procedure compared to the usual methods. Getting moving earlier can sometimes help in recovery.
Researchers will also be carefully checking if the new device is safe to use and if it works well. They want to make sure it doesn't cause any serious problems. The study aims to gather important information that could help improve care for people having this heart procedure in the future.
Key takeaways
- This study compares a new device to traditional methods for closing the entry point after a heart procedure for Atrial Fibrillation.
- The main goal is to see if the new device helps people get up and walk sooner.
- Researchers will also carefully check the device's safety and how well it works.
- Participants will be randomly assigned to either receive the new device or standard care.
- Follow-up includes monitoring during hospital stay and a phone call around 30 days after the procedure.
- You can withdraw from the study at any time without affecting your medical treatment.
Who may be eligible?
To be part of this study, you need to be at least 18 years old and no older than 95. The study is open to everyone, regardless of whether you are male or female.
The most important requirement is that you are having a specific heart procedure for Atrial Fibrillation, which is called an AF ablation. If you're not having this procedure, you won't be able to join the study.
Before you can join, the study team will carefully check to make sure you meet all the requirements. This helps ensure the study is safe for you and that the results are clear.
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, and 95 or younger?
- Are you having an AF ablation procedure?
- Are you able to provide written consent to join the study?
- Are you generally healthy enough to participate in a clinical study?
What does participation involve?
If you decide to join this study, the first step is to read and understand all the information and then give your written consent. Once you agree, you will be randomly assigned to one of two groups, like flipping a coin, so it's a 50/50 chance. One group (50 people) will have the VASCADE MVP device used to close the access site after your heart procedure. The other group (50 people) will have the standard method of closing, which is firm pressure and a special stitch.
The study team will carefully record how long it takes for you to be able to stand up and walk 20 feet (about 6 metres) after your access site is closed. They will also keep track of any problems you might have until you leave the hospital.
After you go home, you'll receive a phone call about 30 days later. This is a routine check-up where they'll ask you some questions using a standard form. They will also record if you needed any pain medication for your access site while you were in the hospital. The total duration of your participation in the study, from your procedure to the phone call, will be about a month.
Potential risks and benefits
Locations (1)
- Asklepios Klinik AltonaVerified postcodeHamburg, Germany· Recruiting
Common questions
What is Atrial Fibrillation (AF)?
Atrial Fibrillation is a condition where the top chambers of your heart beat irregularly and often too fast, which can cause symptoms like palpitations or tiredness.
What is a PVI procedure?
PVI, or Pulmonary Vein Isolation, is a type of heart procedure done to treat Atrial Fibrillation by correcting the electrical signals in your heart.
Will I get the new device or the standard treatment?
You will be randomly assigned to one of two groups. One group gets the new device, and the other gets the standard treatment. It's like a fair coin toss.
How long will I be followed after the procedure?
You will be monitored during your hospital stay, and then there will be a follow-up phone call about 30 days after your procedure.
Is the new device safe?
The study aims to prove the safety and effectiveness of the new device by carefully monitoring participants for any problems.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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