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The Comparison Between the PVAM and CPVI for the Patients of PAF (FORCE-PVA)

Primary Purpose

Atrial Fibrillation, Pulmonary Vein Isolation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pulmonary vein antrum modification
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, pulmonary vein isolation, Contact Force, antrum

Eligibility Criteria

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

Inclusion Criteria:

  • patients with paroxysmal atrial fibrillation refractory to drugs
  • with consent

Exclusion Criteria:

  • LVEF<50%
  • history of cardiac surgery
  • valvular heart disease
  • abnormal thyroid function
  • left atrial thrombus

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PVAM

    Control arm

    Arm Description

    pulomonary vein antrum modification with contact force monitoring for AF

    pulmonary vein isolation without contact force

    Outcomes

    Primary Outcome Measures

    any recorded atrial arrhythmias proved by 7-day holter
    sustained at least 30s

    Secondary Outcome Measures

    procedure time
    time that the patient spend in the procedure room
    x ray time
    x ray spent during the procedure
    adverse event

    Full Information

    First Posted
    December 27, 2016
    Last Updated
    July 19, 2018
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03026413
    Brief Title
    The Comparison Between the PVAM and CPVI for the Patients of PAF
    Acronym
    FORCE-PVA
    Official Title
    The Comparison Between the Pulmonary Vein Antrum Modification by SmartTouch Ablation Catheter With Contact Force Monitoring and Circumferential Pulmonary Vein Isolation by That Without Contact Force Monitoring Plus Lasso Catheter for the Patients of Paroxysmal Atrial Fibrillation: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The First Affiliated Hospital with Nanjing Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To compare the efficacy and safety of circumferential pulmonary vein isolation without contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial fibrillation.
    Detailed Description
    This is a single centre, prospective control study. The study will enroll 180 patients with 2:1 grouped.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation, Pulmonary Vein Isolation
    Keywords
    atrial fibrillation, pulmonary vein isolation, Contact Force, antrum

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    PVAM
    Arm Type
    Experimental
    Arm Description
    pulomonary vein antrum modification with contact force monitoring for AF
    Arm Title
    Control arm
    Arm Type
    Active Comparator
    Arm Description
    pulmonary vein isolation without contact force
    Intervention Type
    Procedure
    Intervention Name(s)
    pulmonary vein antrum modification
    Primary Outcome Measure Information:
    Title
    any recorded atrial arrhythmias proved by 7-day holter
    Description
    sustained at least 30s
    Time Frame
    at least 18 months follow up
    Secondary Outcome Measure Information:
    Title
    procedure time
    Description
    time that the patient spend in the procedure room
    Time Frame
    time during patient enrollment
    Title
    x ray time
    Description
    x ray spent during the procedure
    Time Frame
    time during patient enrollment
    Title
    adverse event
    Time Frame
    at least 18 months follow up

    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: patients with paroxysmal atrial fibrillation refractory to drugs with consent Exclusion Criteria: LVEF<50% history of cardiac surgery valvular heart disease abnormal thyroid function left atrial thrombus

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23515263
    Citation
    Neuzil P, Reddy VY, Kautzner J, Petru J, Wichterle D, Shah D, Lambert H, Yulzari A, Wissner E, Kuck KH. Electrical reconnection after pulmonary vein isolation is contingent on contact force during initial treatment: results from the EFFICAS I study. Circ Arrhythm Electrophysiol. 2013 Apr;6(2):327-33. doi: 10.1161/CIRCEP.113.000374. Epub 2013 Mar 20.
    Results Reference
    result
    PubMed Identifier
    22820056
    Citation
    Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jais P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012 Nov;9(11):1789-95. doi: 10.1016/j.hrthm.2012.07.016. Epub 2012 Jul 20.
    Results Reference
    result
    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/22820056
    Description
    an article about the contact force role in ablation for AF

    Learn more about this trial

    The Comparison Between the PVAM and CPVI for the Patients of PAF

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