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

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ClinicalTrials.gov Identifier: NCT04645342
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : December 7, 2020
Sponsor:
Collaborator:
Baylis Medical Company
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Flutter Device: Baylis Versacross RF wire Device: Baylis RF needle Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Baylis Versacross RF wire
Device: Baylis Versacross radiofrequency wire
Device: Baylis Versacross RF wire
Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure.

Active Comparator: Baylis RF Needle
Device: conventional Baylis radiofrequency needle
Device: Baylis RF needle
Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure.




Primary Outcome Measures :
  1. Time to completion of transseptal puncture [ Time Frame: Day of procedure ]
    Average time in minutes to completion of transseptal puncture during the cardiac ablation procedure


Secondary Outcome Measures :
  1. Number of first attempt transseptal puncture completions [ Time Frame: Day of procedure ]
    Number of times transseptal puncture is completed on first attempt during cardiac ablation procedures

  2. Procedural complications [ Time Frame: Day of procedure and up to 1 day after procedure ]
    Number and severity of procedural complications during cardiac ablation procedures

  3. Number of right atrial needle/wire exchanges [ Time Frame: Day of procedure ]
    Number of right atrial needle/wire exchanges during the cardiac ablation procedure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645342


Contacts
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Contact: Greg Marcus, MD, MAS 415-476-3450 greg.marcus@ucsf.edu
Contact: Thomas Dewland, MD thomas.dewland@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Gregory M Marcus, MD, MAS    415-476-3450    Greg.Marcus@ucsf.edu   
Contact: Thomas Dewland       thomas.dewland@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Baylis Medical Company
Investigators
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Principal Investigator: Greg Marcus, MD, MAS University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04645342    
Other Study ID Numbers: 20-30738
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes