What is the Sphere-360 catheter studying for paroxysmal atrial fibrillation?

The study is evaluating the Sphere-360 Pulsed Field Ablation Catheter combined with the Affera Mapping and Ablation System to assess their safety and effectiveness in treating paroxysmal atrial fibrillation. Researchers aim to understand how well this device controls heart rhythm irregularities and the risks involved. The study is sponsored by Medtronic Cardiac Ablation Solutions and involves several sites across the United States.

Who may be eligible for this paroxysmal atrial fibrillation clinical trial?

Adults aged 18 to 80 years with a diagnosis of recurrent symptomatic paroxysmal atrial fibrillation lasting less than 7 days may be eligible. Participants must be able to comply with study visits and be on oral anticoagulation therapy for at least 3 weeks before the ablation. People with certain heart conditions, implanted devices, or recent cardiac events may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this paroxysmal atrial fibrillation clinical trial?

Study-related care, including the use of the study device and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should be prepared for possible out-of-pocket expenses related to travel or accommodations.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 80Years

All Genders

ID07308847

Study Evaluating the Sphere-360 Catheter and Affera System for Treating Paroxysmal Atrial Fibrillation in Adults Aged 18 to 80

Led by Medtronic Cardiac Ablation Solutions · Updated on 2026-07-24

300

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research evaluates the safety and performance of the Sphere-360 Pulsed Field Ablation Catheter combined with the Affera Mapping and Ablation System for treating people with paroxysmal atrial fibrillation PAF. It is a prospective, single-arm clinical study conducted across multiple sites in the United States. The goal is to analyze key outcomes including freedom from atrial tachyarrhythmia recurrence and any serious device- or procedure-related adverse events. Participants will undergo pulmonary vein isolation ablation using the Sphere-360 catheter and Affera system. This device-based treatment aims to isolate the pulmonary veins to manage PAF symptoms. The study involves a single treatment group and includes follow-up monitoring for up to 12 months after the ablation to assess outcomes. During the study, participants will be evaluated regularly through assessments that monitor their heart rhythm and quality of life. The main outcomes measured include the absence of atrial arrhythmia recurrence for 12 months and the incidence of serious adverse events within 6 months. Quality of life questionnaires will also be completed. The total follow-up period extends for one year after the initial treatment, allowing careful observation of both effectiveness and safety.

CONDITIONS

Brief 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

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosis of recurrent symptomatic paroxysmal atrial fibrillation with episodes lasting longer than 30 seconds but terminating within 7 days
At least 2 symptomatic PAF episodes documented by a physician in the 6 months before enrollment
At least 1 electrocardiographically documented PAF episode within 12 months prior to enrollment
Adults aged 18 to 80 years at 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 by diagnosis
Three or more cardioversions in the 12 months before enrollment
Left atrial anteroposterior dimension greater than 5.0 cm by imaging
Prior left atrial catheter or surgical ablation or percutaneous interventions
Planned left atrial appendage closure or implant of cardiac devices during follow-up
Not on oral anticoagulation therapy for at least 3 weeks before ablation
Presence of permanent pacemaker, biventricular pacemaker, loop recorder, or implantable cardiac defibrillator
Presence of pulmonary vein stents or pre-existing pulmonary vein stenosis
Pre-existing hemidiaphragmatic paralysis
Prior valvular procedures or significant valvular disease
Recent cardiac surgery, myocardial infarction, or coronary interventions within 3 months
Unstable angina or advanced heart failure (NYHA Class III or IV)
Severe lung disease or pulmonary hypertension
Rheumatic heart disease
Severe blood clotting disorders
Contraindications to systemic anticoagulation
Documented left atrial thrombus or active systemic infection
Hypertrophic cardiomyopathy
Known reversible causes of atrial fibrillation
Recent strokes or thromboembolic events within 6 months
Pregnancy or breastfeeding without reliable birth control
Life expectancy less than 12 months
Participation in other unapproved clinical trials
Allergies to adhesives
Body mass index over 40 kg/m2
Atrial myxoma
Significant pulmonary or renal disease
Solid organ or hematologic transplant or evaluation for transplant
Intramural thrombus or vascular access issues
Drug or alcohol dependency
Significant congenital anomalies or medical problems affecting study compliance
Amiodarone treatment within 3 months prior to enrollment
Amyloid heart disease (cardiac amyloidosis)

Research Team

Leah Crocker

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Study Evaluating the Sphere-360 Catheter and Affera System for Treating Paroxysmal Atrial Fibrillation in Adults Aged 18 to 80

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria