HEAL-IST IDE Trial
This research study is investigating a new surgical treatment for a heart condition known as Inappropriate Sinus Tachycardia, or IST. IST causes your heart to beat too fast, even when you're resting, making everyday life difficult for many younger, otherwise healthy individuals. Often, current medicines don't work well enough or cause uncomfortable side effects. This study aims to find out if a specific type of surgery, using a device called the AtriCure ISOLATOR Synergy Surgical Ablation System, is both safe and effective. The goal is to improve symptoms and quality of life for people with IST who haven't found relief with standard treatments.
At a glance
What is this study about?
This study is looking into a new way to treat a heart condition called Inappropriate Sinus Tachycardia (IST). If you have IST, your heart beats too fast, too often, even when you're not exercising or feeling stressed. This can make you feel very tired, breathless, or dizzy, and it can really affect your daily life.
Currently, there aren't many really good treatments for IST, and medicines often don't work well enough or cause side effects. This research wants to see if a special type of surgery, using a device called the AtriCure ISOLATOR Synergy Surgical Ablation System, could be a better option. The surgery aims to fix the part of your heart that's causing the fast beats, while trying to protect the main natural pacemaker of your heart.
The main goals of this study are to check if this surgical procedure is safe and if it actually helps people with IST feel better. By participating, you could help doctors learn more about how to treat this condition and potentially improve the lives of many others who suffer from it.
Key takeaways
- This study tests a new surgery for a fast heart rate called IST.
- It's for people whose IST hasn't improved with other medicines.
- The surgery aims to fix fast heartbeats while protecting your heart's natural rhythm.
- Participation involves surgery and follow-up hospital visits.
- There are potential benefits and risks, as with any medical procedure.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult between 18 and 75 years old and have been diagnosed with Inappropriate Sinus Tachycardia (IST). Importantly, your IST should not have responded well to other medications, or you might have had side effects that stopped you from taking them.
There are also some reasons why you might not be able to join. For example, if you've already had certain heart surgeries or have other serious heart conditions like a very fast heart rate from other causes, or if you have a pacemaker or defibrillator. People who are pregnant or planning to get pregnant, or those with very high body weight, 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.
- Are you between 18 and 75 years old?
- Have you been diagnosed with Inappropriate Sinus Tachycardia (IST)?
- Have medicines for your IST not worked well, or did you have bad side effects?
- Do you not have an existing pacemaker or defibrillator?
- Are you able to attend follow-up appointments?
- Are you not pregnant or planning to become so during the study?
What does participation involve?
If you decide to take part in this study, you would first have a full check-up to make sure you're a good fit. If you are, you would then have the special surgical procedure. After the surgery, you'd need to come back for regular check-ups at the hospital. These visits would allow the doctors to see how you're recovering and how well the treatment is working. They might involve tests like ECGs (heart traces) or blood tests. The study team will explain the full schedule, including how many visits there will be and how long the follow-up period will last in total.
Potential risks and benefits
Locations (27)
- St. BernardVerified postcodeJonesboro, United States
- Loma Linda University HealthVerified postcodeLoma Linda, United States
- Sequoia HospitalVerified postcodeRedwood City, United States
- Stanford UniversityVerified postcodeRedwood City, United States
- Saint Vincent's Medical CenterVerified postcodeBridgeport, United States
- Medstar Washington Hospital CenterVerified postcodeWashington D.C., United States
- University of FloridaVerified postcodeGainesville, United States
- Baptist HealthVerified postcodeMiami, United States
- Sarasota Memorial HospitalVerified postcodeSarasota, United States
- St. Joseph's Hospital / Baycare Health SystemVerified postcodeTampa, United States
- Memorial Health University Medical CenterVerified postcodeSavannah, United States
- Saint Alphonsus Regional Medical CenterVerified postcodeBoise, United States
Common questions
What is Inappropriate Sinus Tachycardia (IST)?
IST is a condition where your heart beats too fast, even when you're resting, causing symptoms like tiredness, breathlessness, and dizziness.
What kind of treatment is being tested?
It's a surgical procedure using a special device called the AtriCure ISOLATOR Synergy Surgical Ablation System, aiming to correct the fast heart rate.
Who is funding this study?
The information provided does not specify the funding body, but clinical trials are often supported by pharmaceutical companies, device manufacturers, or research organizations.
Will I receive new medication?
This study focuses on a surgical procedure rather than a new medication, though you may continue or adjust existing medications as part of your overall care.
What happens if I change my mind during the study?
You are free to leave the study at any point without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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