Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
At a glance
Conditions
NCT07308847
Where you'd take part
This study runs at 24 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Arrhythmia Research Group
Jonesboro, Arkansasno site contact published
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolinano site contact published
Bethesda North Hospital
Cincinnati, Ohiono site contact published
Cleveland Clinic Foundation
Cleveland, Ohiono site contact published
Duke University Medical Center
Durham, North Carolinano site contact published
Icahn School of Medicine at Mount Sinai
New York, New Yorkno site contact published
Inova Fairfax Hospital
Falls Church, Virginiano site contact published
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)
Overland Park, Kansasno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Vivek Reddy, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mt Sinai
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Freedom from Atrial Tachyarrhythmia Recurrence Through 12 Months Post-AblationIndex ablation procedure through 12 months of follow up.
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 procedural failure, repeat ablation, cardioversion, an increase in anti-arrhythmic drugs, or use of amiodarone at any time during the study will constitute a failure.
- Incidence of Device- and Procedure-Related Serious Adverse Events Through 6 MonthsIndex ablation procedure through 6 months of follow up.
Primary safety events (device- and procedure-related serious adverse events, as adjudicated by the Clinical Events Committee) for the Sphere-360 Catheter and Affera Mapping and Ablation System: Within 7 days: heart block, major bleeding needing transfusion, MI, permanent phrenic nerve paralysis, pulmonary edema, severe pericarditis, significant effusion/tamponade, stroke/CVA, systemic/pulmonary embolism needing intervention, TIA, vagal nerve injury causing esophageal dysmotility/gastroparesis, vascular access complications needing intervention, AKI needing dialysis or hospitalization \>48h or prolonged \>48h, death, any device/procedure-related CV/pulmonary event causing/prolonging hospitalization \>48h (excludes recurrent AF/AT/AFL). Within 3 months: atrioesophageal/esophago-pericardial fistula, esophageal perforation (device/procedure related; excludes TEE/nasogastric tube injury). Within 6 months: pulmonary vein stenosis (≥70% diameter reduction).