Trials / Completed
CompletedNCT05120193
Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System
Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 477 (actual)
- Sponsor
- Medtronic Cardiac Ablation Solutions · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. Subjects will be randomly assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System (investigational device) or the THERMOCOOL SMARTTOUCH® SF radiofrequency ablation catheter (control device).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Mapping and Ablation | Minimally invasive catheter mapping and ablation procedure |
Timeline
- Start date
- 2021-12-14
- Primary completion
- 2024-01-10
- Completion
- 2024-01-10
- First posted
- 2021-11-15
- Last updated
- 2025-04-23
- Results posted
- 2025-02-03
Locations
23 sites across 3 countries: United States, Czechia, Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05120193. Inclusion in this directory is not an endorsement.