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NCT04580914 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation
A NA study of Paroxysmal Atrial Fibrillation, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 321
- Enrollment target
- 20
- Study locations
NCT04580914: Completed NA study of Paroxysmal Atrial Fibrillation, sponsored by Boston Scientific Corporation.
NCT04580914 is a NA study of Paroxysmal Atrial Fibrillation that has completed, run by Boston Scientific Corporation. The registered enrollment target is 321 participants, below the 846-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04580914, a NA study of Paroxysmal Atrial Fibrillation, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 321 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The primary safety endpoint at 30 days is defined as the safety event-free rate at 1-Month (30 days) post-procedure.
Conditions Studied
Interventions
- DEVICE Treatment with IntellaNav StablePoint Ablation Catheter
Study Locations (20)
Florida
- AdventHealth Orlando - Orlando
- Sarasota Memorial Hospital - Sarasota
Illinois
- Loyola University Medical Center - Maywood
- St. John's Hospital - Springfield
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
- Mercy Hospital Medical Center - West Des Moines
New York
- Northwell Health - Bay Shore
- Weill Cornell Medical University - New York
Ohio
- Bethesda North Hospital - Cincinnati
- Cleveland Clinic Foundation - Cleveland
Arkansas
- Arrhythmia Research Group - Jonesboro
Hawaii
- The Queen's Medical Center - Honolulu
Idaho
- St. Lukes Idaho Cardiology Associates - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 321 participants |
| Start Date | 2021-04-12 |
| Est. Completion | 2023-06-21 |
| Phase | NA |
What the finished NCT04580914 record still lists
NCT04580914 is an interventional study that assigns participants to a tested intervention. The registered 321 participants enrollment target is mid-sized for trials with a published cap, below the 846-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Paroxysmal Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Treatment with IntellaNav StablePoint Ablation Catheter is the first listed.
NCT04580914 names 20 study sites across 15 states, led by Florida, Illinois, Iowa.
Frequently Asked Questions
What is clinical trial NCT04580914 about?
NCT04580914 is a clinical study titled "Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation". 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.
What is the current status of trial NCT04580914?
This trial is currently completed. It is a NA study. The enrollment target is 321 participants. The study started on 2021-04-12. Estimated completion is 2023-06-21.
What conditions does trial NCT04580914 study?
This clinical trial studies the following conditions: Paroxysmal Atrial Fibrillation.
What interventions are being tested in trial NCT04580914?
The interventions under investigation include: Treatment with IntellaNav StablePoint Ablation Catheter (DEVICE).
Who is sponsoring clinical trial NCT04580914?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04580914 being conducted?
This trial has 20 study locations across Arkansas, Florida, Hawaii, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04580914's enrollment target sits among peer trials
321 7th of 24 higher than 18 of 24 other Paroxysmal Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Paroxysmal Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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