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Completed

NCT Number: NCT04645342

Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baylis Versacross RF wire

Device

Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure.

Baylis RF needle

Device

Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure.

Primary outcomes

  1. Time to Achieve First Transseptal Puncture

    Time frame: 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.

Secondary outcomes

  1. Time to Achieve Second Transseptal Puncture

    Time frame: 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 included in this analysis.

  2. Combined Transseptal Time

    Time frame: 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.

  3. Fluoroscopy Time

    Time frame: 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.

  4. Number of Participants With Equipment Exchanges

    Time frame: (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.

  5. Complication Rates

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Baylis Medical Company

Registry information

Acronym: WIRE-IT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 27, 2020
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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