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NCT07308847 · ClinicalTrials.gov registry record · NA
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
A NA study of Paroxysmal AF, sponsored by Medtronic Cardiac Ablation Solutions.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 9
- Study locations
NCT07308847: Recruiting NA study of Paroxysmal AF, sponsored by Medtronic Cardiac Ablation Solutions.
NCT07308847 is a NA study of Paroxysmal AF that is actively recruiting participants, run by Medtronic Cardiac Ablation Solutions. The registered enrollment target is 300 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07308847, a NA study of Paroxysmal AF, is actively recruiting participants, sponsored by Medtronic Cardiac Ablation Solutions.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
Freedom from documented recurrence of atrial fibrillation, atrial tachycardia, or atrial flutter based on electrocardiographic data through 12 months (365 days) and excluding a 90-day blanking period. The study requires 24-hour Holter monitoring at 6 and 12 months in addition to weekly and symptomatic trans-telephonic monitoring (TTM) transmissions through 12 months, and 12-lead ECGs at all follow up visits. Atrial tachyarrhythmia observed via any of those instruments, as well as acute procedura
Conditions Studied
Interventions
- DEVICE Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
Study Locations (9)
Massachusetts
- Massachusetts General Hospital - Boston
- Southcoast Health System - Fall River
New York
- Icahn School of Medicine at Mount Sinai - New York
- Northwell Health Lenox Hill Hospital - New York
Arkansas
- Arrhythmia Research Group - Jonesboro
Illinois
- Northwestern University - Chicago
North Carolina
- Atrium Health Wake Forest Baptist Medical Center - Winston-Salem
Ohio
- The Ohio State University Wexner Medical Center - Columbus
Texas
- Texas Cardiac Arrhythmia Research Foundation - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2026-01-15 |
| Est. Completion | 2027-11-22 |
| Phase | NA |
What NCT07308847 shows while recruiting
NCT07308847 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Paroxysmal AF appearing as the primary indexed condition, and to 1 intervention - of which Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System is the first listed.
NCT07308847 lists 9 locations in 7 states (Massachusetts, New York, Arkansas).
Frequently Asked Questions
What is clinical trial NCT07308847 about?
NCT07308847 is a clinical study titled "Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)". 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.
What is the current status of trial NCT07308847?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2026-01-15. Estimated completion is 2027-11-22.
What conditions does trial NCT07308847 study?
This clinical trial studies the following conditions: Paroxysmal AF.
What interventions are being tested in trial NCT07308847?
The interventions under investigation include: Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System (DEVICE).
Who is sponsoring clinical trial NCT07308847?
This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07308847 being conducted?
This trial has 9 study locations across Arkansas, Illinois, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Paroxysmal AF
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07308847's enrollment target sits among peer trials
300 330th of 2000 higher than 1,630 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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