Trials / Recruiting
RecruitingNCT05144503
Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation
A Safety and Performance Assessment of the SpherePVI™ Catheter and the Affera Mapping and Ablation System to Treat Paroxysmal Atrial Fibrillation
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Medtronic Cardiac Ablation Solutions · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, single-arm, single-center study to evaluate the safety, performance, and effectiveness of the SpherePVI™ Catheter for treating paroxysmal AF.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SpherePVI™ Catheter | SpherePVI™ Catheter with the Affera Mapping and Ablation System |
Timeline
- Start date
- 2021-07-22
- Primary completion
- 2027-03-15
- Completion
- 2027-10-15
- First posted
- 2021-12-03
- Last updated
- 2026-02-13
Locations
1 site across 1 country: Lithuania
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05144503. Inclusion in this directory is not an endorsement.