Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency

NCT04645342 | Completed Results FDA Device

• 1 other identifier: 20-30738
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Atrial Flutter

Outcome Measures

Primary Outcomes (1)

• 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.

  0-30 minutes (from insertion of guidewire to removal of guidewire of first transseptal)

Secondary Outcomes (5)

• Time to Achieve Second Transseptal Puncture

  0-30 minutes (from insertion of guidewire to removal of guidewire of second transseptal)

• Combined Transseptal Time

  0-60 minutes (summation of first transseptal and second transseptal times)

• Fluoroscopy Time

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

• Number of Participants With Equipment Exchanges

  (0-8 hours) duration of cardiac ablation procedure

• Complication Rates

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

Study Arms (2)

Baylis Versacross RF wire

EXPERIMENTAL

Device: Baylis Versacross radiofrequency wire

Device: Baylis Versacross RF wire

Baylis RF Needle

ACTIVE COMPARATOR

Device: conventional Baylis radiofrequency needle

Device: Baylis RF needle

Interventions

Baylis Versacross RF wire DEVICE

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

Baylis Versacross RF wire

Baylis RF needle DEVICE

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

Baylis RF Needle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Baylis Medical Company: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Thomas Dewland
• Organization: UCSF

thomas.dewland@ucsf.edu

415-476-5706

Study Officials

• Greg Marcus, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: November 30, 2020
• Primary Completion: February 2, 2022
• Study Completion: February 2, 2022
• Last Updated: March 14, 2023
• Results First Posted: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)