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Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency (WIRE-IT)

Primary Purpose

Atrial Fibrillation, Atrial Flutter

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baylis Versacross RF wire
Baylis RF needle
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years old
  • Patients undergoing endocardial left atrial catheter ablation procedures using radiofrequency ablation catheters for atrial fibrillation or atrial flutter ablation procedures at UCSF
  • Willing and able to provide written informed consent in English
  • Willing and able to comply with scheduled remote follow-up visits through 1 Year post-operative

Exclusion Criteria:

  • Presence of a patent foramen ovale closure device or atrial septal defect closure device
  • Cryoballoon ablation
  • IVC filter
  • Deemed not suitable by study personnel

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Baylis Versacross RF wire

Baylis RF Needle

Arm Description

Device: Baylis Versacross radiofrequency wire

Device: conventional Baylis radiofrequency needle

Outcomes

Primary Outcome Measures

Time to Achieve First Transseptal Puncture
First transseptal time was recorded for each participant, starting with insertion of the long guidewire into the femoral short sheath (J wire for RF needle group, VersaCross wire for RF wire group) and stopping once the transseptal sheath was positioned in the LA and the dilator and guidewire were fully removed from the long sheath. Median time in minutes to completion of the first transseptal puncture during the cardiac ablation procedure between the RF needle and RF Wire group was compared as the outcome.

Secondary Outcome Measures

Time to Achieve Second Transseptal Puncture
Second transseptal time was recorded for each participant, starting with insertion of the long guidewire into the femoral short sheath (J wire for RF needle group, VersaCross wire for RF wire group) and stopping once the transseptal sheath was positioned in the LA and the dilator and guidewire were fully removed from the long sheath. The median time in minutes to completion of the second transseptal puncture during the cardiac ablation procedure between the RF needle and RF Wire group was compared as a secondary outcome. Participants that did not undergo 2 transseptal punctures were not included in this analysis.
Combined Transseptal Time
Combined transseptal time was calculated for each participant by summing up participants' first and second transseptal times. The median combined transseptal time in minutes between the RF needle and RF Wire group was compared as a secondary outcome. Participants that did not undergo two transseptal punctures were not included in this analysis.
Fluoroscopy Time
Fluoroscopy time (amount of time operators used fluoroscopy during a transseptal puncture) was recorded for each participant, starting with insertion of the long guidewire into the femoral short sheath (J wire for RF needle group, VersaCross wire for RF wire group) and stopping once the transseptal sheath was positioned in the LA and the dilator and guidewire were fully removed from the long sheath. Median fluoroscopy time during the first and second transseptal punctures between the RF needle and RF Wire group was compared as a secondary outcome.
Number of Participants With Equipment Exchanges
An equipment exchange was defined as the removal of the J or RF wire from the dilator and sheath assembly before transseptal puncture; all RF needle punctures required at least 1 equipment exchange, although further exchanges could be performed as necessary if the initial pull-down resulted in inadequate positioning of the sheath and dilator and readvancement of the transseptal assembly into the SVC was necessary. The number of equipment exchanges during the cardiac ablation procedure between the RF need and RF wire groups were compared.
Complication Rates
The number of participants with complications during the procedure between the RF needle and RF wire groups was compared as a secondary outcome.

Full Information

First Posted
November 20, 2020
Last Updated
March 10, 2023
Sponsor
University of California, San Francisco
Collaborators
Baylis Medical Company
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1. Study Identification

Unique Protocol Identification Number
NCT04645342
Brief Title
Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency
Acronym
WIRE-IT
Official Title
Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
February 2, 2022 (Actual)
Study Completion Date
February 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Baylis Medical Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
This is a randomized controlled trial examining whether Baylis's Versacross RF wire versus the conventional Baylis RF needle is better at puncturing through a thin wall in the heart (called "transseptal puncture") as measured by time to successful transseptal puncture, during cardiac ablation procedures.
Detailed Description
The transseptal puncture is one of the most commonly performed procedures in the cardiac electrophysiology and interventional cardiology laboratories. Indeed, every atrial fibrillation ablation, now the predominant electrophysiology procedure performed throughout the world, routinely involves two different transseptal puncture procedures. The investigators previously performed a randomized, comparative effectiveness trial demonstrating the superiority (in both efficacy and safety) of a radiofrequency (RF) transseptal needle versus the conventional sharp-tipped mechanical needle. More recently, an alternative approach to transseptal puncture has been FDA approved and is already utilized as part of standard of care in these procedures. With this new approach, a J-shaped wire that can transmit RF energy is advanced inside the transeptal sheath rather than the more stiff RF or conventional needle. As advancing a wire is usually a step employed in any transseptal procedure (then usually requiring removal of that wire and then placement of the needle), this new approach saves a step. In addition once the wire has been advanced across the intra-atrial septum into the left atrium, the wire can be used to avoid potentially severe complications; specifically, after a transseptal needle is advanced across the left atrium, advancing the sheath over the needle can result in a sudden jump of all the equipment, risking perforation of the far left atrial wall. With the wire approach, the wire can be safely advanced into a pulmonary vein so that even if the sheath and dilator jump suddenly across the septum, they will be guided along the wire and thereby avoid perforation. The investigators will be studying patients undergoing a catheter ablation procedure at University of California, San Francisco.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baylis Versacross RF wire
Arm Type
Experimental
Arm Description
Device: Baylis Versacross radiofrequency wire
Arm Title
Baylis RF Needle
Arm Type
Active Comparator
Arm Description
Device: conventional Baylis radiofrequency needle
Intervention Type
Device
Intervention Name(s)
Baylis Versacross RF wire
Intervention Description
Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure.
Intervention Type
Device
Intervention Name(s)
Baylis RF needle
Intervention Description
Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure.
Primary Outcome Measure Information:
Title
Time to Achieve First Transseptal Puncture
Description
First transseptal time was recorded for each participant, starting with insertion of the long guidewire into the femoral short sheath (J wire for RF needle group, VersaCross wire for RF wire group) and stopping once the transseptal sheath was positioned in the LA and the dilator and guidewire were fully removed from the long sheath. Median time in minutes to completion of the first transseptal puncture during the cardiac ablation procedure between the RF needle and RF Wire group was compared as the outcome.
Time Frame
0-30 minutes (from insertion of guidewire to removal of guidewire of first transseptal)
Secondary Outcome Measure Information:
Title
Time to Achieve Second Transseptal Puncture
Description
Second transseptal time was recorded for each participant, starting with insertion of the long guidewire into the femoral short sheath (J wire for RF needle group, VersaCross wire for RF wire group) and stopping once the transseptal sheath was positioned in the LA and the dilator and guidewire were fully removed from the long sheath. The median time in minutes to completion of the second transseptal puncture during the cardiac ablation procedure between the RF needle and RF Wire group was compared as a secondary outcome. Participants that did not undergo 2 transseptal punctures were not included in this analysis.
Time Frame
0-30 minutes (from insertion of guidewire to removal of guidewire of second transseptal)
Title
Combined Transseptal Time
Description
Combined transseptal time was calculated for each participant by summing up participants' first and second transseptal times. The median combined transseptal time in minutes between the RF needle and RF Wire group was compared as a secondary outcome. Participants that did not undergo two transseptal punctures were not included in this analysis.
Time Frame
0-60 minutes (summation of first transseptal and second transseptal times)
Title
Fluoroscopy Time
Description
Fluoroscopy time (amount of time operators used fluoroscopy during a transseptal puncture) was recorded for each participant, starting with insertion of the long guidewire into the femoral short sheath (J wire for RF needle group, VersaCross wire for RF wire group) and stopping once the transseptal sheath was positioned in the LA and the dilator and guidewire were fully removed from the long sheath. Median fluoroscopy time during the first and second transseptal punctures between the RF needle and RF Wire group was compared as a secondary outcome.
Time Frame
0-60 minutes (from insertion of guidewire to removal of guidewire of first transseptal and second transseptal)
Title
Number of Participants With Equipment Exchanges
Description
An equipment exchange was defined as the removal of the J or RF wire from the dilator and sheath assembly before transseptal puncture; all RF needle punctures required at least 1 equipment exchange, although further exchanges could be performed as necessary if the initial pull-down resulted in inadequate positioning of the sheath and dilator and readvancement of the transseptal assembly into the SVC was necessary. The number of equipment exchanges during the cardiac ablation procedure between the RF need and RF wire groups were compared.
Time Frame
(0-8 hours) duration of cardiac ablation procedure
Title
Complication Rates
Description
The number of participants with complications during the procedure between the RF needle and RF wire groups was compared as a secondary outcome.
Time Frame
complications were assessed during the duration of cardiac ablation procedure (up to 8 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old Patients undergoing endocardial left atrial catheter ablation procedures using radiofrequency ablation catheters for atrial fibrillation or atrial flutter ablation procedures at UCSF Willing and able to provide written informed consent in English Willing and able to comply with scheduled remote follow-up visits through 1 Year post-operative Exclusion Criteria: Presence of a patent foramen ovale closure device or atrial septal defect closure device Cryoballoon ablation IVC filter Deemed not suitable by study personnel
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Marcus, MD, MAS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency

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