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Evaluating PVI Using CMR

Primary Purpose

Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients (age ≥18 years old)
  • Paroxysmal or persistent AF meeting guideline criteria.
  • Anticipated PVI using index-guided radiofrequency ablation techniques.
  • Availability of LGE-CMR images within 3 months before anticipated PVI.

Exclusion Criteria:

  • History of catheter ablation
  • History of cardiac surgery.
  • History of chest radiation therapy
  • Estimated glomerular filtration rate (eGFR) <45 ml/min/kg
  • Known (or suspected) allergic reaction to gadolinium
  • Contraindications for CMR (such as claustrophobia, certain implants, devices, high body mass index).
  • Inability to schedule CMR <48h after PVI
  • Long-term use of anti-inflammatory medication, except for the use of nonsteroidal anti-inflammatory drugs
  • Autoimmune disease or chronic inflammatory illness.
  • Pregnancy of breast feeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    PVI

    Arm Description

    Outcomes

    Primary Outcome Measures

    Ablaton scar
    The correlation between ablation lesion characteristics in the early phase after PVI and ablation scar at 3 months follow up.

    Secondary Outcome Measures

    AF recurrence
    The relation between ablation lesion characteristics and AF recurrence at 1 year after the ablation procedure

    Full Information

    First Posted
    June 17, 2022
    Last Updated
    June 24, 2022
    Sponsor
    Amsterdam UMC, location VUmc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05437549
    Brief Title
    Evaluating PVI Using CMR
    Official Title
    CMR Characterization of Ablation Lesions Following Pulmonary Vein Isolation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    July 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Amsterdam UMC, location VUmc

    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
    Using state of the art cardiac magnetic resonance imaging techniques, characterization of ablation lesions in the early phase after pulmonary vein isolation ablation in atrial fibrillation patients, and relate findings to the ablation scar at 3 months follow up and atrial fibrillation-free survival at 1 year.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PVI
    Arm Type
    Other
    Intervention Type
    Procedure
    Intervention Name(s)
    MRI
    Intervention Description
    MRI prior to PVI, acutely after PVI, and 3 months after PVI
    Primary Outcome Measure Information:
    Title
    Ablaton scar
    Description
    The correlation between ablation lesion characteristics in the early phase after PVI and ablation scar at 3 months follow up.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    AF recurrence
    Description
    The relation between ablation lesion characteristics and AF recurrence at 1 year after the ablation procedure
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients (age ≥18 years old) Paroxysmal or persistent AF meeting guideline criteria. Anticipated PVI using index-guided radiofrequency ablation techniques. Availability of LGE-CMR images within 3 months before anticipated PVI. Exclusion Criteria: History of catheter ablation History of cardiac surgery. History of chest radiation therapy Estimated glomerular filtration rate (eGFR) <45 ml/min/kg Known (or suspected) allergic reaction to gadolinium Contraindications for CMR (such as claustrophobia, certain implants, devices, high body mass index). Inability to schedule CMR <48h after PVI Long-term use of anti-inflammatory medication, except for the use of nonsteroidal anti-inflammatory drugs Autoimmune disease or chronic inflammatory illness. Pregnancy of breast feeding

    12. IPD Sharing Statement

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    Evaluating PVI Using CMR

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