At a glance
ClinicalIndex Comparison RecordN/ACompleted· 477 enrolled
Drug / intervention
Mapping and Ablationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System
In Brief
A clinical study evaluating Mapping and Ablation for Atrial Fibrillation. Completed, enrolled 477 participants across 23 sites in 3 countries.
Detailed Summary
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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesCzechia, Israel, United States
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
First PostedNov 2021
Enrollment StartDec 2021
Primary CompletionJan 2024
TodayJul 2026
First PostedNov 15, 2021
Enrollment StartDec 14, 2021
Primary CompletionJan 10, 2024
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 4.6 years ago
Interventions
Mapping and Ablationdevice
Minimally invasive catheter mapping and ablation procedure