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Procedure

Patients with atrial fibrillation for Atrial Fibrillation (REAL-AF Trial)

N/A
Recruiting
Research Sponsored by Heart Rhythm Clinical and Research Solutions, LLC
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 post-procedure, 3 months, and 12 months
Awards & highlights

Summary

The primary purpose of this registry is to obtain real-world clinical experience of Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation ablation radiofrequency (RF) technologies. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term, effectiveness of catheter ablation with novel RF technologies in PAF and PsAF patients.

Eligible Conditions
  • Atrial Fibrillation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-procedure, 3 months, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-procedure, 3 months, 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
Effectiveness at 12 months
Effectiveness at 90 days
Long-term Safety
Secondary study objectives
AAD Usage
AF recurrence
AF related symptoms
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with atrial fibrillationExperimental Treatment1 Intervention
Subjects with symptomatic PAF or PsAF who, in the opinion of the investigator, are candidates for ablation for AF, age 18 years or older, and are able and willing to comply with all pre-, post-, and follow-up testing and requirements.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Catheter ablation
2016
Completed Phase 4
~1220

Find a Location

Who is running the clinical trial?

Heart Rhythm Clinical and Research Solutions, LLCLead Sponsor
6 Previous Clinical Trials
2,932 Total Patients Enrolled
6 Trials studying Atrial Fibrillation
2,932 Patients Enrolled for Atrial Fibrillation
Biosense Webster, Inc.Industry Sponsor
125 Previous Clinical Trials
22,057 Total Patients Enrolled
84 Trials studying Atrial Fibrillation
13,974 Patients Enrolled for Atrial Fibrillation
~4916 spots leftby Dec 2027
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