TactiFlex AF IDE Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Paroxysmal Atrial Fibrillation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a prospective, non-randomized, multi-center pivotal clinical trial to evaluate the safety and effectiveness of ablation with the TactiFlex SE catheter for the treatment of PAF compared to pre-determined performance goals. The study design includes a substudy to assure that there will be a statistically sufficient number of subjects ablated at the high-end of the ablation power setting recommendations in the investigational Instructions for Use document. Subjects in the HSP (High Standard Power) substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power. Subjects will be enrolled in either the main study or the substudy at the point of consent.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 130 years
- Gender
- Both males and females
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 de...
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.
Tracking Information
- NCT #
- NCT04356040
- Collaborators
- Not Provided
- Investigators
- Study Director: Kristin Ruffner, PhD Clinical Program Director
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