Actively Recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Led by Medtronic Cardiac Ablation Solutions · Updated on 2026-04-20
300
Participants Needed
12
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years at enrollment
- Diagnosis of recurrent symptomatic paroxysmal atrial fibrillation with episodes lasting longer than 30 seconds but resolving within 7 days
- At least 2 symptomatic PAF episodes within 6 months prior to enrollment documented by a physician
- At least 1 electrocardiographically documented episode within 12 months prior to enrollment
- Willing and able to comply with all baseline and follow-up evaluations for the full study duration
You will not qualify if you...
- Continuous atrial fibrillation lasting more than 7 days or persistent atrial fibrillation
- Having three or more cardioversions for atrial fibrillation in the past 12 months
- Left atrial anteroposterior dimension greater than 5.0 cm
- Prior left atrial catheter or surgical ablation, or prior left atrial percutaneous interventions such as left atrial appendage occlusion or septal closure devices
- Planned left atrial appendage closure or implantation of certain cardiac devices during follow-up
- Not on oral anticoagulation therapy for at least 3 weeks prior to ablation
- Presence of permanent pacemaker, biventricular pacemaker, loop recorder, or implantable cardiac defibrillator
- Presence of pulmonary vein stents or known pulmonary vein stenosis
- Pre-existing hemidiaphragmatic paralysis
- Prior valvular surgical or percutaneous procedures or atriotomy
- Moderate to severe aortic or mitral valve stenosis or mitral regurgitation (3+ or 4+)
- Recent cardiac surgery, myocardial infarction, PCI/PTCA, or coronary artery stenting within 3 months
- Unstable angina
- NYHA Class III or IV heart failure or left ventricular ejection fraction ≤40%, or planned transplant or LVAD
- Severe lung disease or primary pulmonary hypertension requiring oxygen
- Rheumatic heart disease
- Severe blood clotting or bleeding disorders
- Contraindication or unwillingness to use systemic anticoagulation
- Documented left atrial thrombus
- Active systemic infection or sepsis
- Hypertrophic cardiomyopathy
- Known reversible causes of atrial fibrillation such as uncontrolled hyperthyroidism, severe untreated sleep apnea, or acute alcohol toxicity
- Recent cerebral ischemic events, carotid procedures, or thromboembolic events
- Pregnancy, breastfeeding, or women not using reliable birth control
- Life expectancy insufficient for 12-month follow-up
- Participation in other clinical trials not approved by Medtronic
- Allergies to adhesives
- Body mass index over 40 kg/m2
- Atrial myxoma
- Significant restrictive or obstructive pulmonary disease
- Severe renal impairment or dialysis
- Solid organ or hematologic transplant or evaluation for transplant
- Vascular abnormalities preventing catheter use
- Drug or alcohol dependency
- Significant congenital or medical problems affecting study participation
- Treatment with Amiodarone within 3 months prior to enrollment
- Amyloid heart disease (cardiac amyloidosis)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Arrhythmia Research Group
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
2
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Southcoast Health System
Fall River, Massachusetts, United States, 02720
Actively Recruiting
5
The Valley Hospital
Paramus, New Jersey, United States, 07652
Actively Recruiting
6
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
7
Northwell Health Lenox Hill Hospital
New York, New York, United States, 10075
Actively Recruiting
8
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
9
Bethesda North Hospital
Cincinnati, Ohio, United States, 45220
Actively Recruiting
10
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
11
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Actively Recruiting
12
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Actively Recruiting
Research Team
L
Leah Crocker
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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