This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac electrophysiological mapping and for the treatment of drug-refractory, recurrent symptomatic persistent atrial fibrillation (AF) when used in conjunction with a compatible radiofrequency (RF) generator and three-dimensional mapping system. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter for the treatment of drug refractory, symptomatic persistent atrial fibrillation in the United States.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
224
Ablation procedure for Persistent AF
University Hospital (UAB)
Birmingham, Alabama, United States
St. Bernards
Jonesboro, Arkansas, United States
Arkansas Heart Hosptial
Little Rock, Arkansas, United States
Scripps Health
La Jolla, California, United States
Sequoia Hospital
Redwood City, California, United States
South Denver Cardiology Associates
Littleton, Colorado, United States
Florida Hospital
Orlando, Florida, United States
Emory University Hosptial
Atlanta, Georgia, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Johns Hopkins University Hospital
Baltimore, Maryland, United States
...and 12 more locations
Rate of Subjects With a Device and/or Procedure-related SAE.
Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device.
Time frame: Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure
Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence.
The following events were considered a failure for AF/AFL/AT recurrence: * If AF/AFL/AT recurrence (\>30 second episode) occurred at any time after the therapy consolidation period (\>180 days after the initial procedure), or * If the subject required a repeat procedure for the treatment of AF after the therapy consolidation period, the subject was considered an effectiveness endpoint failure regardless of documentation of a \>30 second AF/AFL/AT episode, or * If the subject required a second repeat procedure at any time after the initial procedure, or * If the subject required a new AAD or a previously failed AAD at a dose greater than the highest ineffective historical dose for AF after the therapy consolidation period, or * If the subject required a cardioversion (electrical or pharmacological) for the treatment of AF after the therapy consolidation period, or * If the subject had a continuous atrial arrhythmia throughout a 12-lead ECG recording after the the
Time frame: 15 months
Acute Procedural Success
Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins
Time frame: Immediate post procedure
15-month Success Off of Antiarrhythmic Drugs
Percent of subjects off all AADs taken to treat AF/AFL/AT who achieve15-month success, defined as freedom from documented AF/AFL/AT recurrence (episodes \>30 seconds) during the 9-month period following the blanking and therapy consolidation periods.
Time frame: 15 months
15 Month Single Procedure Success
Percent of subjects who achieve 15-month single procedure success, defined as freedom from documented AF/AFL/AT recurrence (episodes \>30 seconds) during the 9-month period following the blanking and therapy consolidation periods after a single ablation procedure. Any repeat ablation procedure required by the subject at any time was deemed an effectiveness failure in this analysis.
Time frame: 15 months
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