Purpose of this Study
We are doing this study to test an experimental technology called the TactiFlex Pulsed Field Ablation (PFA) System. We want to know if it can improve outcomes for people with AFib who are candidates for a catheter ablation procedure.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with symptomatic, paroxysmal AFib
- Are not responding to drug treatment options
- Are a candidate for a catheter ablation procedure
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will undergo a catheter ablation procedure (which is intended to maintain or restore a normal heart rhythm and reduce abnormal heart rhythms) using the TactiFlex Pulsed Field Ablation (PFA) System. PFA therapy is an FDA-approved treatment for AFib, but the new technology used in this study is not approved and still undergoing testing.
The rest of your care will be the same as if you were not in the study. You will be in the study for approximately 12 months following the procedure. After you are discharged from the hospital following your procedure, you will have follow-up visits at the following times:
- 7 days after your proceduure
- 5 weeks after your procedure
- 3 months after your procedure
- 6 months after your procedure
- 12 months after your procedure
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
CRD 1074 FlexPulse - Safety and effectiveness of the TactiFlex SE Catheter and Volt Pulsed Field Ablation (PFA) Generator in subjects with paroxysmal atrial fibrillation
Principal Investigator
Jonathan
Piccini
Protocol Number
PRO00116614
NCT ID
NCT06676072
Phase
II
Enrollment Status
Open to Enrollment