TactiFlex AF IDE Trial

  • STATUS
    Recruiting
  • End date
    Dec 5, 2022
  • participants needed
    355
  • sponsor
    Abbott Medical Devices
Updated on 5 June 2021
Investigator
George Galoussian
Primary Contact
IKEM Prague (1.2 mi away) Contact
+43 other location
radiofrequency ablation
catheter ablation
antiarrhythmic drug
af 3

Summary

Prospective, non-randomized multi-center clinical investigation. Design includes a main study and a separate substudy. Subjects in the main study are to be treated using the full range of ablation power settings in the IFU. Subjects in the substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).

Description

This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiFlexTM Ablation Catheter, Sensor EnabledTM (TactiFlex SE) for treating symptomatic drug-refractory paroxysmal atrial fibrillation. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiFlex SE catheter worldwide. Three hundred fifty-five (355) subjects will be enrolled at up to 50 investigational sites worldwide. This clinical investigation is sponsored by Abbott.

The TactiFlex IDE Clinical Study will enroll a total of 355 subjects.

Details
Condition Arrhythmia, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Atrial Fibrillation (Pediatric), Dysrhythmia, paroxysmal af
Treatment TactiFlex SE, TactiFlex SE - HSP
Clinical Study IdentifierNCT04356040
SponsorAbbott Medical Devices
Last Modified on5 June 2021

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