NCT04356040

TactiFlex Paroxysmal Atrial Fibrillation IDE Trial

Safety and Effectiveness of the TactiFlex(TM) Ablation Catheter, Sensor Enabled(TM) (TactiFlex SE) for Treating Drug-refractory, Symptomatic Atrial Fibrillation.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated using the full range of ablation power settings in the Instructions For Use. Subjects in the High Standard Power Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).

Detailed description

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

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	TactiFlex SE	Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.
DEVICE	TactiFlex SE - High Standard Power	Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the 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.

Timeline

• Start date: 2020-06-29
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2020-04-21
• Last updated: 2023-10-31
• Results posted: 2023-10-31

Locations

45 sites across 10 countries: United States, Australia, Austria, Canada, Czechia, Germany, Hong Kong, Italy, Netherlands, Taiwan

Regulatory

• FDA-regulated device study