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.
Who Can Participate?
Eligibility
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.
Age Range
18-80
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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).
Locations
Other
Visit Timing
Weekdays
Evenings
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
Horizon 360 protocol for the Treatment of Paroxysmal Atrial Fibrillation with the Sphere-360? Catheter and Affera? Mapping and Ablation System
Principal Investigator
Jonathan
Piccini
Protocol Number
PRO00118273
NCT ID
NCT07308847
Phase
III
Enrollment Status
Pending Open to Enrollment