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Procedure

Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures (REDO-FIRM Trial)

N/A
Waitlist Available
Led By Vivek Reddy, MD
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-month post procedure
Awards & highlights
No Placebo-Only Group

Summary

A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.

Eligible Conditions
  • Atrial Fibrillation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-month post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month post procedure 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 Atrial Fibrillation Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Recurrence at 12 Months Post Procedure.
Freedom From Serious Adverse Events Related to the Procedure

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: FIRM-guided Procedure and PVIExperimental Treatment1 Intervention
FIRM-guided procedure followed by PVI.
Group II: Standard PVIActive Control1 Intervention
Standard catheter ablation including pulmonary vein isolation (PVI) procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FIRM-Guided Procedure and PVI
2016
N/A
~620

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Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
652 Previous Clinical Trials
416,568 Total Patients Enrolled
77 Trials studying Atrial Fibrillation
32,246 Patients Enrolled for Atrial Fibrillation
Vivek Reddy, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
35 Previous Clinical Trials
12,751 Total Patients Enrolled
19 Trials studying Atrial Fibrillation
7,297 Patients Enrolled for Atrial Fibrillation
Stefan G. Spitzer, MDPrincipal InvestigatorPraxisklinik Herz und Gefäße Dresden, Germany
1 Previous Clinical Trials
456 Total Patients Enrolled
~28 spots leftby Dec 2025
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