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Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency

NCT04645342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-03-14

Study results available
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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

Interventions

DEVICE

Baylis Versacross RF wire

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

DEVICE

Baylis RF needle

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

Sponsors & Collaborators

Principal Investigators

  • Greg Marcus, MD, MAS · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2022-02-02
Completion
2022-02-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04645342 on ClinicalTrials.gov