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Ablation Catheter

Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation (NEwTON AF Trial)

N/A
Waitlist Available
Led By Gregory Michaud
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new device to treat atrial fibrillation, a heart condition. The device is called the IntellaNav StablePoint Catheter and Force-Sensing System.

Eligible Conditions
  • Atrial Fibrillation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Freedom from Treatment Failure at 12-Months Post-Procedure
Freedom from Treatment Failure at 6-Months Post-Procedure
Number of Participants that achieved electrical isolation of all pulmonary veins
+2 more
Secondary study objectives
Freedom from documented symptomatic Atrial Fibrillation, Atrial Flutter and Atrial Tachycardia Recurrence
Freedom from primary effectiveness failure without a repeat procedure
Number of patients with New or Increased Dose of AAD
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment with Ablation CatheterExperimental Treatment1 Intervention
Patients who undergo treatment with the ablation catheter for the treatment of paroxysmal atrial fibrillation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment with IntellaNav StablePoint Ablation Catheter
2021
N/A
~330

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Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
746 Previous Clinical Trials
857,668 Total Patients Enrolled
78 Trials studying Atrial Fibrillation
34,176 Patients Enrolled for Atrial Fibrillation
Gregory MichaudPrincipal InvestigatorMassachusetts General Hospital
~68 spots leftby Jan 2026
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