DiamondTemp Global Registry
The DiamondTemp™ Global Registry is a study for people with an irregular heartbeat, also known as arrhythmia. It's collecting information from many hospitals around the world where patients are being treated with a special device called the DiamondTemp™ Ablation System. This system is already available for use. The main goal is to understand more about how well this treatment works in real-life situations and to make sure it's safe for a wide range of patients. Researchers will follow patients for at least 12 months after their treatment, checking in with them as they would normally. This study simply observes what's happening, without trying new things, to gather valuable insights into this treatment.
At a glance
What is this study about?
This study, called the DiamondTemp™ Global Registry, is about a treatment for an irregular heartbeat, which doctors call arrhythmia. An irregular heartbeat can make you feel tired, dizzy, or short of breath, and sometimes it can be more serious. The treatment being looked at here is called the DiamondTemp™ Ablation System.
This isn't a study where doctors are testing a brand new drug or device. Instead, it's observing how a treatment that's already used in hospitals works in many different patients around the world. The aim is to gather information on how well the DiamondTemp™ Ablation System performs in a variety of people and to monitor its safety during everyday medical care. This helps doctors and researchers understand the treatment better in real-world settings.
Patients who are treated with the DiamondTemp™ Ablation System will have their health monitored for at least 12 months after their procedure, just as they normally would. The study simply records this information. This way, researchers can learn a lot from how the treatment works for many different people over time, helping to improve care for future patients with irregular heartbeats.
Key takeaways
- This study looks at an existing treatment for irregular heartbeats called DiamondTemp™ Ablation.
- It's an observational study, meaning researchers watch how the treatment works in real patients.
- The goal is to understand how well it works and if it's safe for many different people.
- You would be followed for at least 12 months after your procedure.
- Participation involves sharing information from your regular medical care, not extra procedures or visits.
Who may be eligible?
To take part in this study, you must be at least 18 years old. Also, you need to be scheduled to have a procedure using the DiamondTemp™ Ablation System as part of your regular treatment for an irregular heartbeat.
It's important that you are willing to follow the study's requirements and give your permission to be included. This means signing a form that states you understand what the study involves and that you agree to share your medical information for research purposes.
There are a few reasons why you might not be able to join. For example, if you're already participating in another medical study that hasn't approved you joining this one, or if there are specific local rules that would prevent your participation, you might not be eligible.
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?
- Are you scheduled to have a DiamondTemp™ Ablation procedure?
- Are you willing to agree to the study requirements?
- Are you able to provide your written consent to participate?
What does participation involve?
If you decide to take part, you wouldn't need extra hospital visits or special tests just for the study. You would receive your DiamondTemp™ Ablation procedure as planned, and your doctors would follow up with you as they normally would after the treatment. The study simply collects information from these routine appointments and check-ups. You would be followed for at least 12 months after your procedure, which means the study would track your progress for about a year or more. There are no new medications involved that are specific to the study, and your treatment plan remains your doctor's decision.
Potential risks and benefits
Locations (21)
- Sunshine Coast University HospitalVerified postcodeBirtinya, Australia
- Fiona Stanley HospitalVerified postcodeMurdoch, Australia
- Universitair Ziekenhuis BrusselVerified postcodeJette, Belgium
- CHRU de Tours - Hôpital TrousseauVerified postcodeChambray-lès-Tours, France
- Capio - Clinique du TonkinVerified postcodeVilleurbanne, France
- Herz- und Diabeteszentrum NRW - Ruhr-Universität BochumVerified postcodeBad Oeynhausen, Germany
- Universitäres HerzzentrumVerified postcodeHamburg, Germany
- Saint Vincenz Krankenhaus PaderbornVerified postcodePaderborn, Germany
- Humanitas Mater DominiVerified postcodeCastellanza, Italy
- Ospedale di Conegliano - S. Maria dei BattutiVerified postcodeConegliano, Italy
- Ospedale dell'AngeloVerified postcodeVenezia, Italy
- Catharina ZiekenhuisVerified postcodeEindhoven, Netherlands
Common questions
What is an arrhythmia?
An arrhythmia is when your heart beats with an irregular or abnormal rhythm, either too fast, too slow, or unevenly.
What is the DiamondTemp™ Ablation System?
It's a medical device used by doctors to treat certain types of irregular heartbeats.
Is this a new treatment being tested?
No, the DiamondTemp™ Ablation System is already approved and used in hospitals. This study is observing how it works in real patients.
How long will I be involved in the study?
You'll be followed for at least 12 months after your procedure, as part of your standard medical care.
Will I have to do extra things if I join?
No, you won't have extra visits or tests for the study. Information will be collected from your routine medical appointments.
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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