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Procedure

FIRM-guided Procedure and PVI for Atrial Fibrillation (REAFFIRM Trial)

N/A
Waitlist Available
Led By Johannes Brachmann, 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 up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

The study is a prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM procedures followed by conventional ablation including PVI versus a standard PVI procedure for the treatment of persistent atrial fibrillation (AF).

Eligible Conditions
  • Atrial Fibrillation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 standard catheter ablation including PVI.
Group II: Standard PVI AblationActive Control1 Intervention
Standard catheter ablation including pulmonary vein isolation (PVI) procedure for the treatment of persistent AF.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FIRM-Guided Procedure and PVI
2016
N/A
~620

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
650 Previous Clinical Trials
415,993 Total Patients Enrolled
76 Trials studying Atrial Fibrillation
31,690 Patients Enrolled for Atrial Fibrillation
Johannes Brachmann, MDPrincipal InvestigatorKlinikum Coburg GmbH
1 Previous Clinical Trials
447 Total Patients Enrolled
~32 spots leftby Nov 2025
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