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Procedure
Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency (WIRE-IT Trial)
N/A
Waitlist Available
Led By Greg Marcus, MD, MAS
Research Sponsored by University of California, San Francisco
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 0-60 minutes (summation of first transseptal and second transseptal times)
Awards & highlights
No Placebo-Only Group
Summary
This trial is comparing two ways of puncturing through a thin wall in the heart, to see which is better.
Eligible Conditions
- Atrial Flutter
- Atrial Fibrillation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-60 minutes (summation of first transseptal and second transseptal times)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-60 minutes (summation of first transseptal and second transseptal times)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to Achieve First Transseptal Puncture
Secondary study objectives
Combined Transseptal Time
Complication Rates
Fluoroscopy Time
+2 moreAwards & 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: Baylis Versacross RF wireExperimental Treatment1 Intervention
Device: Baylis Versacross radiofrequency wire
Group II: Baylis RF NeedleActive Control1 Intervention
Device: conventional Baylis radiofrequency needle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baylis Versacross RF wire
2020
N/A
~80
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,875 Total Patients Enrolled
1 Trials studying Atrial Flutter
Baylis Medical CompanyIndustry Sponsor
9 Previous Clinical Trials
705 Total Patients Enrolled
Greg Marcus, MD, MASPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
120 Total Patients Enrolled