Abbott has announced first enrolments in the TactiFlex PAF IDE study to evaluate a new device to treat people suffering from paroxysmal atrial fibrillation (PAF). The study will evaluate the performance of the investigational TactiFlex ablation catheter, sensor enabled (SE) for people whose atrial fibrillation (AF) symptoms are unable to be managed by medication.
The TactiFlex PAF IDE study will enroll 355 patients at multiple sites worldwide. Patients enrolled in the trial will receive an ablation procedure using Abbott’s TactiFlex ablation catheter, SE. Data collected from the study will be submitted to support global regulatory approvals.
Physicians use tools, such as contact force technology, during ablation procedures to help them apply the right amount of pressure to the heart tissue to improve procedural effectiveness. Additionally, physicians use magnetically sensor enabled technology, such as the TactiCath contact force ablation catheter, sensor enabled, for precise location and navigation within the heart.
“The TactiFlex device builds on prior generations of successful technology, giving me confidence that Abbott will continue providing options to effectively treat people living with recurrent episodes of atrial fibrillation,” said Prash Sanders, director of Centre for Heart Rhythm Disorders at The Royal Adelaide Hospital, Adelaide, Australia.
“Abbott is focused on bringing innovation to physicians that can improve how people with AF are treated. The TactiFlex ablation catheter, SE brings the best of Abbott’s ablation technologies into a single catheter,” said Mike Pederson, senior vice president of Abbott’s electrophysiology and heart failure businesses.
The TactiFlex Ablation Catheter, SE is being clinically evaluated as part of the TactiFlex PAF IDE—a global study—and is not yet commercially available.