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Remote Magnetic Versus Manual Navigation-guided Ablation for Non-outflow Tract Premature Ventricular Contractions: a Prospective, Randomized, Controlled Trial

Primary Purpose

Premature Ventricular Contraction

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Catheter Ablation
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ventricular Contraction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. non-outflow tract PVCs
  2. Holter>10,000/24h or PVCs load>10%
  3. the first ablation procedure
  4. failure of at least one AAD to treat PVCs before ablation

Exclusion Criteria:

  1. PVC ablation history
  2. HF with NYHA IV
  3. 3 months prior to AMI or PCI
  4. Cardiac thrombosi
  5. Hyperthyroidism
  6. Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Remote magnetic navigation group

    Mannual control navigation group

    Arm Description

    PVC ablation with RMN

    PVC ablation with mannual navigation

    Outcomes

    Primary Outcome Measures

    Freedom rate of PVC
    Efficacy endpoint
    Procedure-related Complications
    Safety endpoint

    Secondary Outcome Measures

    fluoroscopic time
    ablation time
    procedure time

    Full Information

    First Posted
    August 17, 2020
    Last Updated
    August 18, 2020
    Sponsor
    Ruijin Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04519112
    Brief Title
    Remote Magnetic Versus Manual Navigation-guided Ablation for Non-outflow Tract Premature Ventricular Contractions: a Prospective, Randomized, Controlled Trial
    Official Title
    Department of Cardiology, Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    September 30, 2022 (Anticipated)
    Study Completion Date
    September 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ruijin Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This prospective, randomized, controlled trial is designed to compare the safety and efficacy of remote magnetic navigation-guided ablation for ventricular premature complexes arising from non-outflow tracts with manual control navigation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Ventricular Contraction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Remote magnetic navigation group
    Arm Type
    Experimental
    Arm Description
    PVC ablation with RMN
    Arm Title
    Mannual control navigation group
    Arm Type
    Active Comparator
    Arm Description
    PVC ablation with mannual navigation
    Intervention Type
    Procedure
    Intervention Name(s)
    Catheter Ablation
    Intervention Description
    Catheter Ablation with RMN and MCN
    Primary Outcome Measure Information:
    Title
    Freedom rate of PVC
    Description
    Efficacy endpoint
    Time Frame
    one year
    Title
    Procedure-related Complications
    Description
    Safety endpoint
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    fluoroscopic time
    Time Frame
    one day
    Title
    ablation time
    Time Frame
    one day
    Title
    procedure time
    Time Frame
    one day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: non-outflow tract PVCs Holter>10,000/24h or PVCs load>10% the first ablation procedure failure of at least one AAD to treat PVCs before ablation Exclusion Criteria: PVC ablation history HF with NYHA IV 3 months prior to AMI or PCI Cardiac thrombosi Hyperthyroidism Pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qi Jin, MD
    Phone
    +8613020144766
    Email
    jinqi127@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32413467
    Citation
    Noten AME, Hendriks AA, Yap SC, Mol D, Bhagwandien R, Wijchers S, Kardys I, Khan M, Szili-Torok T. Contact feedback improves 1-year outcomes of remote magnetic navigation-guided ischemic ventricular tachycardia ablation. Int J Cardiol. 2020 Sep 15;315:36-44. doi: 10.1016/j.ijcard.2020.05.028. Epub 2020 May 12.
    Results Reference
    result
    PubMed Identifier
    29957265
    Citation
    Qiu X, Zhang N, Luo Q, Liu A, Ji Y, Ye J, Lin C, Ling T, Chen K, Pan W, Zhao J, Jin Q, Wu L. Remote magnetic navigation facilitates the ablations of frequent ventricular premature complexes originating from the outflow tract and the valve annulus as compared to manual control navigation. Int J Cardiol. 2018 Sep 15;267:94-99. doi: 10.1016/j.ijcard.2018.03.105.
    Results Reference
    result

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    Remote Magnetic Versus Manual Navigation-guided Ablation for Non-outflow Tract Premature Ventricular Contractions: a Prospective, Randomized, Controlled Trial

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