Horizon 360 - Clinical Trial
What is the Purpose of this Study?
After joining the study, each person will have several checkups. These include the first visit, the ablation procedure, and a visit before going home. There will also be a phone call about one week later, a visit around one month later, and visits at three months, six months, and twelve months. These visits help doctors check how the heart is doing over time.
The Sphere 360 Catheter is a tool that helps doctors study the electrical signals in the heart. It can also be used to treat a heart rhythm problem called paroxysmal atrial fibrillation, which causes the heart to beat in an uneven way.
Who Can Participate in the Study?
This study is for adults who are between 18 and 80 years old and have a heart rhythm problem called paroxysmal atrial fibrillation. This means they have episodes of an irregular heartbeat that last more than 30 seconds but stop on their own or with treatment within seven days. To join, a person must have had at least two episodes in the last six months and one episode recorded on a heart test in the last year. People must also be willing and able to come to all study visits and follow all study instructions.
What is Involved?
The purpose of the study is to provide data demonstrating the safety and effectiveness of the Sphere-360 Catheter and Affera Mapping and Ablation System for treating paroxysmal atrial fibrillation (PAF).
Study Details
