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Ablation System

St. Jude Medical Cardiac Ablation System for Atrial Fibrillation (IRASE-AF Trial)

N/A
Waitlist Available
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.

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
Incidence of Adverse Events Included in the Pre-specified Composite
Secondary study objectives
Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: St. Jude Medical Cardiac Ablation SystemExperimental Treatment1 Intervention
Group II: FDA approved Open Irrigated Radio Frequency Ablation SystemActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SJM Irrigated Cardiac Ablation System
2010
N/A
~330

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
652 Previous Clinical Trials
416,513 Total Patients Enrolled
77 Trials studying Atrial Fibrillation
32,191 Patients Enrolled for Atrial Fibrillation
~21 spots leftby Nov 2025
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