Trials / Recruiting
RecruitingNCT05115214
Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation
A Safety and Performance Assessment of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Medtronic Cardiac Ablation Solutions · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI™ Multi-Ablation System for treating paroxysmal atrial fibrillation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SpherePVI™ Catheter | Affera SpherePVI™ Multi-Ablation System |
Timeline
- Start date
- 2021-10-19
- Primary completion
- 2027-03-15
- Completion
- 2027-10-15
- First posted
- 2021-11-10
- Last updated
- 2026-02-13
Locations
2 sites across 1 country: Czechia
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05115214. Inclusion in this directory is not an endorsement.