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

NCT04580914 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2025-01-16

Study results available
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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.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

Treatment with IntellaNav StablePoint Ablation Catheter

Patients will be treated with an ablation catheter

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Gregory Michaud · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2023-06-21
Completion
2023-06-21
FDA Device
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • Monaco
  • Netherlands
  • Taiwan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04580914 on ClinicalTrials.gov