Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. Subjects will be randomly assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System (investigational device) or the THERMOCOOL SMARTTOUCH® SF radiofrequency ablation catheter (control device).

Key facts

Study ID

NCT05120193

Run by

Medtronic Cardiac Ablation Solutions

People needed

477

Starts

2021-12-14

Expected to finish

2024-01-10

Last updated by the study team

2025-04-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Symptomatic PerAF documented by (1) a physician's note indicating symptoms consistent with AF sustained longer than 7 days but less than 12 months; AND either (2a) a 24-hour Holter documenting continuous AF within the past year OR (2b) two electrocardiograms (from any form of rhythm monitoring, including consumer devices) taken at least 7 days apart within the past year, each showing continuous AF.
• Failure or intolerance of at least one Class I or III anti-arrhythmic drug (AAD).
• Suitable candidate for catheter ablation.
• Adults aged 18 - 80 years.
• Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
• Willing and able to provide informed consent.

You may not qualify if…

• Continuous AF lasting for 12 months or longer.
• AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause.
• Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure).
• Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
• Any carotid stenting or endarterectomy.
• Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure.
• Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure.
• Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure.
• Presence of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function).
• Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure.
• Documented left atrial thrombus on imaging.
• History of blood clotting or bleeding abnormalities.
• Any condition contraindicating chronic anticoagulation.
• Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.
• Body mass index >40 kg/m2.
• Left atrial diameter >55 mm (anterioposterior).
• Diagnosed atrial myxoma.
• Left ventricular ejection fraction (EF) < 35%.
• Uncontrolled heart failure or NYHA Class III or IV heart failure.
• Rheumatic heart disease.
• Hypertrophic cardiomyopathy.
• Unstable angina.
• Moderate to severe mitral valve stenosis.
• Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
• Primary pulmonary hypertension.

Where it is running

• Arrhythmia Institute at Grandview — Birmingham, Alabama, United States
• Banner University Medical Center Phoenix — Phoenix, Arizona, United States
• Arrhythmia Research Group — Jonesboro, Arkansas, United States
• Pacific Heart Institute — Santa Monica, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Naples Heart Institute — Naples, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Northwell Health — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• The OhioHealth Research Institute — Columbus, Ohio, United States
• Doylestown Hospital — Doylestown, Pennsylvania, United States
• University of Pittsburgh Medical Center Pinnacle Health — Wormleysburg, Pennsylvania, United States
• Vanderbilt Medical Center — Nashville, Tennessee, United States
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States
• Nemocnice Ceske Budejovice — České Budějovice, Czechia
• Institut Klinicke a Experimentani Mediciny — Prague, Czechia
• Nemocnice Na Homolce — Prague, Czechia
• Shamir Medical Center — Zrifin, Israel

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.