This study was a randomized trial evaluating the safety, effectiveness, and efficiency of the Sphere-9™ catheter with the Affera™ mapping and ablation system for the treatment of patients with persistent atrial fibrillation.
SPHERE Per-AF was a randomized controlled trial (RCT) comparing the Affera™ mapping and ablation system with Sphere-9™ catheter to the CARTO®* navigation and mapping system with THERMOCOOL SMARTTOUCH®* SF (STSF) catheter for the treatment of drug-refractory patients with persistent atrial fibrillation. All 420 primary analysis patients received pulmonary vein isolation (PVI) and additional linear lesions were permitted in order to treat documented macro reentrant tachycardias.
3 countries
United States, Israel, Czechia
23 sites
> 40 operators
420 patients treated
in primary analysis
< 12 months
to complete enrollment
The Sphere-9™ catheter with Affera™ mapping and ablation system displayed proven safety and effectiveness with superior efficiency.
Adjunctive linear ablation with Sphere-9™ catheter resulted in a trend toward increased effectiveness versus PVI only in this persistent AF patient cohort.3
THERMOCOOL SMARTTOUCH®* SF catheter
Sphere-9™ catheter
One catheter to map, ablate, and validate in more than 97% of procedures.
Two catheters needed in all procedures: one to map and validate and another to ablate.
SPHERE Per-AF: Late-breaking data and IDE experience with the Sphere-9™ catheter
Watch Vivek Reddy, MD; Elad Anter, MD; and Khaldoun Tarakji, MD, review results from the SPHERE Per-AF IDE Trial.
Affera™ mapping and ablation system with Sphere-9™ dual-energy catheter case presentation and discussion
Watch Andrea Sarkozy, MD; Andrea Natale, MD; Moussa Mansour, MD; and Erich Kiehl, MD, discuss the operator learning curves from the SPHERE per-AF IDE Trial.
Access detailed product information, including spec sheets, videos, and presentations.
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