At a glance
ClinicalIndex Comparison RecordN/ACompleted· 74 enrolled
Drug / intervention
Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation Systemdevice
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.
An Initial Assessment of Safety and Performance of the Sphere-9™ Catheter and System for Mapping and Ablation of Atrial and Ventricular Arrhythmias
In Brief
A clinical study evaluating Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System for Atrial Fibrillation and 2 related conditions. Completed, enrolled 74 participants across 2 sites.
Detailed Summary
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and RF Ablation System to treat Atrial Arrhythmias
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Atrial Flutter, Ventricular Tachycardia
CountriesCzechia
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
Enrollment StartJun 2018
Primary CompletionSep 2019
First PostedDec 2019
Study CompletionSep 2020
TodayJul 2026
First PostedDec 26, 2019
Enrollment StartJun 1, 2018
Primary CompletionSep 2, 2019
Study CompletionSep 18, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.5 years ago
Interventions
Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation Systemdevice
Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System