The objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and effective for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).
This is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory PAF.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
Deliver RF and/or PF energy using the TactFlex PFA system
Proportion of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7 days of any ablation procedure (index or repeat procedure performed 0-90 days post initial procedure).
Time frame: 7 days
Freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of greater than 30 seconds duration that are documented by protocol-specified 12-lead ECG, TTM or Holter monitor (HM) devices after the index ablation procedure
Time frame: 12 months
Symptomatic Effectiveness
Freedom from documented symptomatic AF/AF/AT episodes of greater than 30 seconds duration that are documented by protocol-specific 12-lead ECG, TTM or Holter monitor devices after the index ablation procedure.
Time frame: 12 months
AAD-Free Effectiveness
Freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of \> 30 seconds duration that are documented by protocol-specific 12-lead ECG, TTM, or Holter monitor after the index ablation procedure. Any use of Class I or III antiarrythmic drugs after the 90-day blanking period will count as a therapy failure in the analysis
Time frame: 12 months
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HonorHealth
Scottsdale, Arizona, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Stanford University Medical Center
Stanford, California, United States
South Denver Cardiology Associates PC
Littleton, Colorado, United States
HCA Florida Mercy Hospital
Miami, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Piedmont Athens Regional Medical Center
Athens, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas, United States
...and 22 more locations