Evaluating the QDOT MICRO System for Atrial Fibrillation
This study is looking at the long-term safety and effectiveness of a medical device called the QDOT MICRO System, used with the VISITAG SURPOINT Module, to treat symptomatic paroxysmal atrial fibrillation (a type of irregular heartbeat that starts and stops on its own). Researchers want to see how well this system works and if it's safe for people who haven't responded to other treatments. You might be able to join if you are 18 or older, have this type of atrial fibrillation, and your doctor thinks you could benefit from an ablation procedure (a treatment that uses heat or cold to create tiny scars in the heart to block faulty electrical signals). The study aims to enroll 250 participants, but its current status is unclear.
- Study design
- This is an observational study, meaning researchers will watch how the QDOT MICRO System is used in real-world settings. It is a sub-study within a larger registry, and it is not randomized.
- What's involved
- You would need to complete scheduled assessments within 12 months after your ablation procedure, and then two more assessments at 24 and 36 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety for 7 days after the procedure, and for effectiveness at 12 months, 24 months, and 36 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.
At a glance
Conditions
NCT06324201
Where you'd take part
This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Allegheny Health
Pittsburgh, Pennsylvaniano site contact published
Recruiting
Arrhythmia Institute at Grandview
Birmingham, Alabamano site contact published
Recruiting
Bon Secours Medical Group - Richmond Specialty Care
Richmond, Virginiano site contact published
Recruiting
Centra Health, Inc.dba Stroobants Cardiovascular Center
Lynchburg, Virginiano site contact published
Recruiting
Community Memorial Health System
Ventura, Californiano site contact published
Recruiting
Franciscan Heart and Vascular Associates
Tacoma, Washingtonno site contact published
Recruiting
Medical City - HCA
Aurora, Coloradono site contact published
Recruiting
Mercy Health
Janesville, Wisconsinno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Brian Sanchez, MD · STUDY_DIRECTOR · J & J Corporation
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT ModuleDay 0-7 post ablation
Adverse events from post-procedure through 7-day post ablation visit.
- Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 12-months.12 months
Freedom from atrial arrhythmia recurrence at 12 months post procedure.
- Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months.24 months
Freedom from atrial arrhythmia recurrence at 24 months post procedure.
- Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months.36 months
Freedom from atrial arrhythmia recurrence at 36 months post procedure.