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Individualised Mapping in Persistent AF Ablation (IMAGE AF)

Primary Purpose

Persistent Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonary veins isolation + Cartofinder-guided ablation
Pulmonary veins isolation
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
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, catheter ablation, individualized mapping, focal activity, rotational activity

Eligibility Criteria

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

Inclusion Criteria:

  1. Age > 18 years old
  2. Signed informed consent.
  3. Scheduled to undergo a clinically indicated, first-time catheter ablation procedure for the treatment of persistent atrial fibrillation.
  4. In atrial fibrillation at the time of the index procedure.

Exclusion Criteria:

  1. Paroxysmal atrial fibrillation.
  2. Previous ablation procedure for atrial fibrillation.
  3. Left ventricular ejection fraction < 45%
  4. Obesity with BMI > 35 kg/m2
  5. Congenital heart disease.
  6. Previous cardiac surgery with atriotomy.
  7. Previous left atrial appendage closure/ligation.
  8. Contraindications to systemic anticoagulation, catheter ablation, and/or general anaesthesia.
  9. Pregnancy
  10. Current enrolment in a study evaluating another device or drug.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    PVI only

    PVI + IM

    Arm Description

    Patients in this arm will undergo only standard pulmonary veins isolation with radiofrequency (RF) energy to treat their AF.

    Patients in this arm will undergo standard wide area circumferential pulmonary veins isolation along with radiofrequency energy and additional RF ablation guided by individualised mapping with Cartofinder to treat their AF.

    Outcomes

    Primary Outcome Measures

    Freedom from atrial arrhythmia
    Freedom from any atrial arrhythmia without the use of antiarrhythmic drugs

    Secondary Outcome Measures

    Freedom from atrial fibrillation
    Freedom from atrial fibrillation without the use of antiarrhythmic drugs
    Atrial fibrillation burden reduction
    Reduction of the atrial fibrillation burden by 75% compared to baseline
    Absolute atrial fibrillation burden
    Absolute atrial fibrillation burden after a single, first-time ablative procedure guided by individualised mapping vs. standard approach.

    Full Information

    First Posted
    September 22, 2021
    Last Updated
    September 22, 2021
    Sponsor
    Royal Brompton & Harefield NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05065112
    Brief Title
    Individualised Mapping in Persistent AF Ablation
    Acronym
    IMAGE AF
    Official Title
    Individualised MApping-Guided Ablation to Improve Outcomes in pErsistent Atrial Fibrillation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2021 (Anticipated)
    Primary Completion Date
    November 2024 (Anticipated)
    Study Completion Date
    May 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Royal Brompton & Harefield NHS Foundation Trust

    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
    A clinical randomised trial to compare strategies for ablation in persistent and long-standing persistent atrial fibrillation comprising of two arms: pulmonary veins isolation (PVI) only and PVI + individualised mapping-guided ablation (Cartofinder, Biosense Webster Inc.)

    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, catheter ablation, individualized mapping, focal activity, rotational activity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    212 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PVI only
    Arm Type
    Active Comparator
    Arm Description
    Patients in this arm will undergo only standard pulmonary veins isolation with radiofrequency (RF) energy to treat their AF.
    Arm Title
    PVI + IM
    Arm Type
    Experimental
    Arm Description
    Patients in this arm will undergo standard wide area circumferential pulmonary veins isolation along with radiofrequency energy and additional RF ablation guided by individualised mapping with Cartofinder to treat their AF.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pulmonary veins isolation + Cartofinder-guided ablation
    Intervention Description
    The individualised mapping with Cartofinder intends to identify areas with the repetitive atrial activation patterns which are targeted with focal or linear ablation anchored on at least one end in an anatomical or electrical barrier.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pulmonary veins isolation
    Intervention Description
    Wide area circumferential pulmonary veins isolation
    Primary Outcome Measure Information:
    Title
    Freedom from atrial arrhythmia
    Description
    Freedom from any atrial arrhythmia without the use of antiarrhythmic drugs
    Time Frame
    12 monts
    Secondary Outcome Measure Information:
    Title
    Freedom from atrial fibrillation
    Description
    Freedom from atrial fibrillation without the use of antiarrhythmic drugs
    Time Frame
    12 months
    Title
    Atrial fibrillation burden reduction
    Description
    Reduction of the atrial fibrillation burden by 75% compared to baseline
    Time Frame
    12 months
    Title
    Absolute atrial fibrillation burden
    Description
    Absolute atrial fibrillation burden after a single, first-time ablative procedure guided by individualised mapping vs. standard approach.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > 18 years old Signed informed consent. Scheduled to undergo a clinically indicated, first-time catheter ablation procedure for the treatment of persistent atrial fibrillation. In atrial fibrillation at the time of the index procedure. Exclusion Criteria: Paroxysmal atrial fibrillation. Previous ablation procedure for atrial fibrillation. Left ventricular ejection fraction < 45% Obesity with BMI > 35 kg/m2 Congenital heart disease. Previous cardiac surgery with atriotomy. Previous left atrial appendage closure/ligation. Contraindications to systemic anticoagulation, catheter ablation, and/or general anaesthesia. Pregnancy Current enrolment in a study evaluating another device or drug.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vias Markides, MD, FESC
    Phone
    020 7352 8121
    Email
    v.markides@imperial.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vias Markides, MD, FESC
    Organizational Affiliation
    Royal Brompton Hospital, London, UK
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Individualised Mapping in Persistent AF Ablation

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