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Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation (RECREATION Study) (RECREATION)

Primary Purpose

Persistent Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remote magnetic navigation
Cryoablation
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring persistent atrial fibrillation, remote magnetic navigation, cryoablation

Eligibility Criteria

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

Inclusion Criteria:

  1. Persistent atrial fibrillation (>7d, < 5years)
  2. Age 18-75 years
  3. Patient is mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol

Exclusion Criteria:

  1. Any previous left atrial ablation or surgery
  2. Any cardiac surgery or percutaneous coronary intervention within 3 months prior to enrollment
  3. Stroke or transient ischemic attack within 6 months prior to enrollment
  4. Myocardial infarction within 3 months prior to enrollment
  5. Anteroposterior left atrial diameter > 55 mm

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Remote magnetic navigation

    Cryoablation

    Arm Description

    Persistent atrial fibrillation ablation with remote magnetic navigation

    Persistent atrial fibrillation ablation with cryoballoon

    Outcomes

    Primary Outcome Measures

    Clinical efficacy (time to first AF recurrence after blanking period)
    the time to first AF recurrence after blanking period (month)
    Clinical safety (Any procedure-related complications)
    Any procedure-related complications

    Secondary Outcome Measures

    Procedure time (min)
    Time to first cardiovascular hospitalization (month)
    QoL of 12 months (Units on a Scale)
    X-ray time (min)

    Full Information

    First Posted
    January 30, 2017
    Last Updated
    September 5, 2019
    Sponsor
    Ruijin Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03044925
    Brief Title
    Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation (RECREATION Study)
    Acronym
    RECREATION
    Official Title
    Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation: A Prospective, Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    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

    5. Study Description

    Brief Summary
    Compare the safety and efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.
    Detailed Description
    Compare the efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation. Compare the safety of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation. Compare the procedural parameters of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation. Compare the effects of amiodarone on recurrence after these two different ablation procedures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Persistent Atrial Fibrillation
    Keywords
    persistent atrial fibrillation, remote magnetic navigation, cryoablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Remote magnetic navigation
    Arm Type
    Experimental
    Arm Description
    Persistent atrial fibrillation ablation with remote magnetic navigation
    Arm Title
    Cryoablation
    Arm Type
    Active Comparator
    Arm Description
    Persistent atrial fibrillation ablation with cryoballoon
    Intervention Type
    Procedure
    Intervention Name(s)
    Remote magnetic navigation
    Intervention Description
    Pulmonary vein isolation and other areas ablation guided by remote magnetic navigation
    Intervention Type
    Procedure
    Intervention Name(s)
    Cryoablation
    Intervention Description
    Pulmonary vein isolation and other areas ablation used by cryoballoon
    Primary Outcome Measure Information:
    Title
    Clinical efficacy (time to first AF recurrence after blanking period)
    Description
    the time to first AF recurrence after blanking period (month)
    Time Frame
    one year
    Title
    Clinical safety (Any procedure-related complications)
    Description
    Any procedure-related complications
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Procedure time (min)
    Time Frame
    one week
    Title
    Time to first cardiovascular hospitalization (month)
    Time Frame
    one year
    Title
    QoL of 12 months (Units on a Scale)
    Time Frame
    one year
    Title
    X-ray time (min)
    Time Frame
    one week

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Persistent atrial fibrillation (>7d, < 5years) Age 18-75 years Patient is mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol Exclusion Criteria: Any previous left atrial ablation or surgery Any cardiac surgery or percutaneous coronary intervention within 3 months prior to enrollment Stroke or transient ischemic attack within 6 months prior to enrollment Myocardial infarction within 3 months prior to enrollment Anteroposterior left atrial diameter > 55 mm
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Qi Jin, MD
    Organizational Affiliation
    Ruijin Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27042964
    Citation
    Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
    Results Reference
    result
    PubMed Identifier
    27381589
    Citation
    Kuck KH, Furnkranz A, Chun KR, Metzner A, Ouyang F, Schluter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kuhne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016 Oct 7;37(38):2858-2865. doi: 10.1093/eurheartj/ehw285. Epub 2016 Jul 5.
    Results Reference
    result
    PubMed Identifier
    27738068
    Citation
    Kuniss M, Greiss H, Pajitnev D, Akkaya E, Deubner N, Hain A, Bodammer L, Berkowitsch A, Chierchia GB, Hamm CW, Neumann T. Cryoballoon ablation of persistent atrial fibrillation: feasibility and safety of left atrial roof ablation with generation of conduction block in addition to antral pulmonary vein isolation. Europace. 2017 Jul 1;19(7):1109-1115. doi: 10.1093/europace/euw146.
    Results Reference
    result
    PubMed Identifier
    26969219
    Citation
    Jin QI, Pehrson S, Jacobsen PK, Chen XU. Efficacy and Safety of Atrial Fibrillation Ablation Using Remote Magnetic Navigation: Experience from 1,006 Procedures. J Cardiovasc Electrophysiol. 2016 Mar;27 Suppl 1:S23-8. doi: 10.1111/jce.12929.
    Results Reference
    result

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    Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation (RECREATION Study)

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