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

NCT07308847 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Paroxysmal AF

Interventions

DEVICE

Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System

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

Sponsors & Collaborators

  • Medtronic Cardiac Ablation Solutions

    lead INDUSTRY

Principal Investigators

  • Vivek Reddy, MD · Icahn School of Medicine at Mt Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2027-11-22
Completion
2027-11-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07308847 on ClinicalTrials.gov