N/A
Completed N=16
An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System
Source: ClinicalTrials.gov NCT04210622 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Number of Subjects With a Primary Safety Event — 0 Participants
Summary
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and Ablation System to treat Atrial Arrhythmias
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With a Primary Safety Event |
— | — |
| PRIMARY Number of Positive (Affirmative) Product Performance Responses |
16 | — |
| SECONDARY Number of Subjects Free From Documented Recurrence |
16 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 and 50 mmHg)
- Enrollment in any other ongoing study protocol that would interfere with this study.
- Documented severely impaired kidney function defined as Cockcroft-Gault Glomerular Filtration Rate (GFR) 200 mm Hg within last 30 days.
- Severe bleeding, clotting or thrombotic disorder.
- Uncontrolled diabetes.
- Women who are pregnant or are not willing to use contraception for the duration of the study.
- Severe chronic obstructive pulmonary disease (COPD; identified by a forced expiratory volume [FEV1] 55 mm (parasternal view).
- Prior atrial septal defect (ASD) or patent foramen ovale (PFO) closure with a device using a transcatheter percutaneous approach.
- Hypertrophic cardiomyopathy defined as left ventricular (LV) septal wall thickness >1.5cm.
- Prior ablation or surgery for atrial fibrillation.
- NYHA Class III or IV
Data sourced from ClinicalTrials.gov (NCT04210622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.