At a glance
ClinicalIndex Comparison RecordN/ACompleted· 321 enrolled
Drug / intervention
Treatment with IntellaNav StablePoint Ablation Catheterdevice
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.
Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation
In Brief
A clinical study evaluating Treatment with IntellaNav StablePoint Ablation Catheter for Paroxysmal Atrial Fibrillation. Completed, enrolled 321 participants across 47 sites in 13 countries.
Detailed Summary
The NEwTON AF study is a multi-center, global, prospective, single arm study to establish the safety and effectiveness of the IntellaNav StablePoint Catheter and Force-Sensing System in subjects with symptomatic, drug refractory, recurrent paroxysmal atrial fibrillation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Atrial Fibrillation
CountriesAustria, Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Monaco, Netherlands, Taiwan, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedOct 2020
Enrollment StartApr 2021
Primary CompletionJun 2023
TodayJul 2026
First PostedOct 9, 2020
Enrollment StartApr 12, 2021
Primary CompletionJun 21, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.7 years ago
Interventions
Treatment with IntellaNav StablePoint Ablation Catheterdevice
Patients will be treated with an ablation catheter