This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). 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 in the United States. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. This clinical investigation is sponsored by Abbott.
This is a prospective, multi-center, single-arm clinical trial to demonstrate the acute safety and effectiveness of the TactiCath SE catheter for the treatment of PAF against a performance goal. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. Only sites that enroll at least one subject will be part of the analysis population. No center may contribute more than 20% of the total number of enrollments without sponsor pre-approval to exceed this proportion and at least 50% of subjects must be from the United States.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
156
Ablation to achieve pulmonary vein isolation.
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Scripps Health
La Jolla, California, United States
Sequoia Hospital
Redwood City, California, United States
South Denver Cardiology Associates, P.C.
Littleton, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Florida Hospital
Orlando, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Mayo Clinic
Rochester, Minnesota, United States
New York University Hospital
New York, New York, United States
...and 11 more locations
Rate of Serious Adverse Events
The primary safety endpoint is the rate of device or procedure-related serious adverse events occurring within 7 days of the index procedure. SAEs related solely to arrhythmia recurrence (without coexisting conditions such as thromboembolism, worsening heart failure, etc.) will not be considered primary safety endpoint events. The SAEs that will be included in this endpoint are: * Atrial-esophageal fistula * AV block * Cardiac Perforation/ Tamponade * Death * Diaphragmatic paralysis * Gastroparesis * Hospitalization * Myocardial Infarction * Pericarditis * Pneumothorax * Pulmonary edema * Pulmonary vein stenosis * Stroke * Thromboembolism * Transient ischemic attack * Vascular access complications Atrial-esophageal fistula, cardiac perforation/tamponade, and pulmonary vein stenosis that occur \>7 days post procedure through 30 days will also contribute to the primary endpoint.
Time frame: 30 days
Number of Participants With Procedural Success
The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins
Time frame: 0 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.