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COMPLETED NA

Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation

NCT04580914 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 321 participants
Start Date 2021-04-12
Est. Completion 2023-06-21
Phase NA

Sponsor

Boston Scientific Corporation

120 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04580914

The ClinicalTrials.gov registry entry for NCT04580914 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 321 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04580914 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, Illinois, Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04580914?

The interventions under investigation include: Treatment with IntellaNav StablePoint Ablation Catheter (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04580914?

This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial