N/A
Completed N=74
Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System for Treatment of Atrial and Ventricular Arrhythmias
Atrial Fibrillation · atrial flutter · Ventricular Tachycardia
Source: ClinicalTrials.gov NCT04211441 ↗
Enrolled (actual)
74
Serious AEs
7.2%
Results posted
May 2025
Primary outcomePrimary: Percentage of Subjects With a Primary Safety Event — 2 Participants
Summary
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and RF Ablation System to treat Atrial Arrhythmias
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With a Primary Safety Event |
2 | — |
| PRIMARY Number of Positive (Affirmative) Product Performance Responses |
69 | — |
| SECONDARY Percentage of Subjects Free From Documented Recurrence |
19 | — |
| SECONDARY Number of Patients With Durable Ablation Lesions at Remapping Procedure |
19 | — |
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] 1.5cm.
- Any other condition that, in the opinion of the investigator, poses a significant hazard to the subject if an ablation procedure was performed.
Additional exclusion criteria for AF patients only:
- Left atrial diameter of >55 mm (parasternal view).
- Prior ablation or surgery for atrial fibrillation.
Data sourced from ClinicalTrials.gov (NCT04211441). 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.