Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
200 participants
OBSERVATIONAL
2025-09-25
2030-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System
NCT05120193
An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System
NCT04210622
Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System for Treatment of Atrial and Ventricular Arrhythmias
NCT04211441
Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)
NCT07298473
Clinical Performance of the Globe® Mapping and Ablation System for the Treatment of Atrial Fibrillation
NCT04954911
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Persistent Atrial Fibrillation
Sphere-9™ Catheter and Affera™ Ablation System
De novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sphere-9™ Catheter and Affera™ Ablation System
De novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Refractory (i.e. not effective, not tolerated, or not desired) to at least one Class I or III antiarrhythmic drug (AAD)
3. Patient is ≥ 18 years of age
4. Planned de novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera Ablation System
5. Patient is willing and able to comply with study requirements and give informed consent
Exclusion Criteria
2. Prior left atrial catheter or surgical ablation
3. Life expectancy \<36 months
4. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
5. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Cardiac Ablation Solutions
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic
Rochester, Minnesota, United States
Montefiore Medical Center
New York, New York, United States
OhioHealth
Columbus, Ohio, United States
Doylestown Health Cardiology
Doylestown, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Texas Health Resources
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Centra Medical Group Stroobants Cardiovascular Center
Lynchburg, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPHERE Per-AF PAS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.