Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)

Conditions

• Paroxysmal AF

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System — DEVICE
  Pulmonary Vein Isolation using the Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System

Study Details

The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.

Key Dates

First listed

Dec 30, 2025

Start date

Jan 15, 2026

Status verified

Jun 2026

Primary completion

Nov 22, 2027

Completion

Nov 22, 2027

Study Design

Enrollment

300 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Pulmonary Vein Isolation Ablation
  Pulmonary Vein Isolation Ablation utilizing the Sphere-360 and Affera Mapping and Ablation System

Primary Outcome Measure

Freedom from Atrial Tachyarrhythmia Recurrence Through 12 Months Post-Ablation [ Time Frame: Index ablation procedure through 12 months of follow up. ]

Central Contacts

• Leah Crocker
  763-526-6237
  [email protected]

Locations (22)

Find similar trials in Jonesboro, AR

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