NCT04645342: WIRE-IT

Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency

Completed NA Results posted Last updated 14 March 2023

What this trial tests

NA trial testing Baylis Versacross RF wire in Atrial Fibrillation in 75 participants. Completed in 2 February 2022.

Timeline

30 November 2020

Primary endpoint
2 February 2022

2 February 2022

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	75
Start date	30 November 2020
Primary completion	2 February 2022
Estimated completion	2 February 2022
Sites	1 location across United States

Drugs / interventions tested

• Baylis Versacross RF wire
• Baylis RF needle

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Atrial Flutter — all drugs for Atrial Flutter →

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Atrial Fibrillation or Atrial Flutter. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Achieve First Transseptal Puncture Primary · 0-30 minutes (from insertion of guidewire to removal of guidewire of first transseptal)

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.

Group	Value	95% CI
Baylis RF Needle	9.2	5.7 – 11.2
Baylis Versacross RF Wire	6.9	5.2 – 8.4

Time to Achieve Second Transseptal Puncture Secondary · 0-30 minutes (from insertion of guidewire to removal of guidewire of second transseptal)

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 includ

Group	Value	95% CI
Baylis RF Needle	8.4	5.5 – 13.4
Baylis Versacross RF Wire	6.0	4.9 – 7.8

Combined Transseptal Time Secondary · 0-60 minutes (summation of first transseptal and second transseptal times)

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.

Group	Value	95% CI
Baylis RF Needle	20.5	14 – 27.7
Baylis Versacross RF Wire	14.0	10.6 – 15.6

Fluoroscopy Time Secondary · 0-60 minutes (from insertion of guidewire to removal of guidewire of first transseptal and second transseptal)

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.

1st Transseptal

Group	Value	95% CI
Baylis RF Needle	2.0	1.6 – 3.2
Baylis Versacross RF Wire	1.8	1.3 – 2.2

2nd Transseptal

Group	Value	95% CI
Baylis RF Needle	2.4	1.6 – 3.5
Baylis Versacross RF Wire	1.8	1.5 – 2.7

Number of Participants With Equipment Exchanges Secondary · (0-8 hours) duration of cardiac ablation procedure

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.

Number of exchanges = 0

Group	Value	95% CI
Baylis RF Needle	0
Baylis Versacross RF Wire	37

Number of exchanges = 1

Group	Value	95% CI
Baylis RF Needle	26
Baylis Versacross RF Wire	0

Number of exchanges = 2

Group	Value	95% CI
Baylis RF Needle	5
Baylis Versacross RF Wire	2

Number of exchanges >= 3

Group	Value	95% CI
Baylis RF Needle	5
Baylis Versacross RF Wire	0

Complication Rates Secondary · complications were assessed during the duration of cardiac ablation procedure (up to 8 hours)

The number of participants with complications during the procedure between the RF needle and RF wire groups was compared as a secondary outcome.

Group	Value	95% CI
Baylis RF Needle	1
Baylis Versacross RF Wire	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected over 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Baylis RF Needle

Serious: 0/36 (0%)

Deaths: 0/36

Baylis Versacross RF Wire

Serious: 0/39 (0%)

Deaths: 0/39

Other adverse events (1 terms — click to expand)

Reaction	System	Baylis RF Needle	Baylis Versacross RF Wire
Procedure Complications (temporary AV Block)	Cardiac disorders	—	—

Data from ClinicalTrials.gov NCT04645342 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.