N/A Completed N=74 Treatment

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)

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.

View full record on ClinicalTrials.gov →

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.