Trials / Completed
CompletedNCT06271967
FOCALFLEX (CE Mark) Study
A Study of FOCAL Pulsed Field Ablation With the TactiFLEX SE Catheter and Volt Generator for the Treatment of Paroxysmal Atrial Fibrillation (FOCALFLEX)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This clinical investigation is intended to demonstrate safety and effectiveness of the TactiFlex™ Ablation Catheter Sensor Enabled™, the Volt™ Pulse Field Ablation (PFA) Generator, and EnSite™ X EP System with EnSite™ Pulsed Field Ablation Software for the treatment of symptomatic, recurrent paroxysmal atrial fibrillation (PAF).
Detailed description
This is a pre-market, prospective, single-arm, non-randomized, multicenter clinical investigation. Up to 150 subjects will be enrolled in this clinical investigation at up to 25 investigational sites worldwide. The clinical investigation is sponsored by Abbott.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TactiFlex™ Ablation Catheter Sensor Enabled™ | Pulsed field ablation (PFA)/radiofrequency (RF) ablation with the TactiFlex™ Ablation Catheter Sensor Enabled™ |
Timeline
- Start date
- 2024-08-15
- Primary completion
- 2025-07-09
- Completion
- 2026-01-19
- First posted
- 2024-02-22
- Last updated
- 2026-02-05
Locations
24 sites across 11 countries: Australia, Austria, Belgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06271967. Inclusion in this directory is not an endorsement.