SPHERE Per-AF Post-Approval Study
Purpose
SPHERE Per-AF Post-Approval Study is a prospective, multi-center, non-randomized, observational trial. Subjects will be treated with the Sphere-9™ Catheter and Affera™ Ablation System and followed through 36 months.
Condition
- Persistent Atrial Fibrillation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- A diagnosis of recurrent symptomatic persistent AF (continuous AF sustained longer than 7 days but less than 12 months) 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
- Long-standing persistent AF (continuous AF sustained >12 months) 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Persistent Atrial Fibrillation |
|
Recruiting Locations
University of Alabama at Birmingham Hospital
Birmingham 4049979, Alabama 4829764 35294
Birmingham 4049979, Alabama 4829764 35294
More Details
- Status
- Recruiting
- Sponsor
- Medtronic Cardiac Ablation Solutions
Detailed Description
The purpose of the study is to evaluate the long-term effectiveness and safety of the Sphere-9™ Catheter and Affera™ Ablation System in a post-approval setting for the treatment of drug refractory, recurrent, symptomatic, persistent AF (episode duration less than one year).