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Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Esophageal Temperature-Guided Ablation
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Cryoballoon Pulmonary Vein Isolation, Esophageal Effects

Eligibility Criteria

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

Inclusion Criteria:

  1. Recurrent, symptomatic, drug-refractory, paroxysmal atrial fibrillation with planned cryoballoon pulmonary vein isolation
  2. Age >18 years
  3. Planned AF cryoablation procedure

Exclusion Criteria:

  1. LA diameter >55mm
  2. Severe LVH (LV wall ≥ 15mm)
  3. LA thrombus
  4. Decompensated heart failure
  5. Plans for left atrial ablation lesions beyond isolation of the pulmonary veins
  6. History of previous pulmonary vein isolation
  7. Inability to place esophageal temperature probe or TEE probe
  8. Previously documented phrenic nerve injury
  9. Known esophageal pathology (complete GI history worksheet)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Multi-center, prospective outcomes registry

    Arm Description

    The study is a multi-center, prospective outcomes registry

    Outcomes

    Primary Outcome Measures

    Temperature Decline
    I. To determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation procedure.
    Measurements of esophagus to each pulmonary vein
    II. To accurately measure the distance between the esophagus and the ostium of each pulmonary vein intra-operatively.
    Create Recommendations for esophageal temperature-guided ablation
    To attempt to create recommendations for esophageal temperature-guided ablation in order to increase the safety profile of cryoballoon pulmonary vein isolation (PVI) by providing one center's experience. By trending cryoballoon ablation temperatures and subsequent esophageal temperatures, data trends may emerge and be predictive for esophageal ulceration formation. These trends may include: Distance between esophagus and pulmonary vein in patients who developed post-ablation esophageal ulcerations Intra-procedure esophageal temperatures in patients who developed post-ablation esophageal ulcerations Intra-procedure cryoballoon temperatures in patients who developed post-ablation esophageal ulcerations
    Assessment of additional Adverse Events
    To associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations.

    Secondary Outcome Measures

    Data collection on Phrenic Injury
    Assess participants with abnormal imaging and/or adverse events that are related to the treatment.

    Full Information

    First Posted
    November 18, 2016
    Last Updated
    February 17, 2021
    Sponsor
    Baylor Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02998866
    Brief Title
    Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects
    Official Title
    Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    February 23, 2018 (Actual)
    Study Completion Date
    February 23, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Baylor Research Institute

    4. Oversight

    5. Study Description

    Brief Summary
    To determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation.
    Detailed Description
    When treating atrial fibrillation and targeting various areas in the left atrium, electrophysiologists have the choice to perform ablation with RF energy or cryoenergy. Esophageal ulceration and in more rare cases, esophageal fistulae, are known complications of this ablation procedure. Though rare (0.1-0.25% fistula rate and 15-20% esophageal ulceration rate according to the most recent Heart Rhythm Society EHRA ECA consensus statement)1, the investigators would very much like to understand how to completely prevent these occurrences. Cryoenergy has more recently been introduced as an energy source used in the PVI procedure; therefore, for this energy source, rates of esophageal ulceration are not yet well-defined. Nine esophageal fistulae have occurred in the first approximately 130,000 cryoballoon procedures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Paroxysmal Atrial Fibrillation
    Keywords
    Cryoballoon Pulmonary Vein Isolation, Esophageal Effects

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Multi-center, prospective outcomes registry
    Arm Type
    Other
    Arm Description
    The study is a multi-center, prospective outcomes registry
    Intervention Type
    Procedure
    Intervention Name(s)
    Esophageal Temperature-Guided Ablation
    Intervention Description
    Esophageal temperature-guided ablation (if esophageal temperatures drop too low during cryoablation, the physician will stop the ablation) in order to increase the safety profile of cryoballoon pulmonary vein (a vein carrying blood from the participants lungs to the left side of the participants heart known as the left atrium) isolation (PVI [means a balloon shaped catheter will be placed at the opening of each pulmonary vein and tissue will be cooled in order to create an ablation line (line of scar tissue) between the left side of the participants heart and each pulmonary vein. This is done to prevent the triggers that typically cause intermittent atrial fibrillation (known as Paroxsymal Atrial Fibrillation) by providing one center's experience.
    Primary Outcome Measure Information:
    Title
    Temperature Decline
    Description
    I. To determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation procedure.
    Time Frame
    90 days or when complications resolve
    Title
    Measurements of esophagus to each pulmonary vein
    Description
    II. To accurately measure the distance between the esophagus and the ostium of each pulmonary vein intra-operatively.
    Time Frame
    90 days or when complications resolve
    Title
    Create Recommendations for esophageal temperature-guided ablation
    Description
    To attempt to create recommendations for esophageal temperature-guided ablation in order to increase the safety profile of cryoballoon pulmonary vein isolation (PVI) by providing one center's experience. By trending cryoballoon ablation temperatures and subsequent esophageal temperatures, data trends may emerge and be predictive for esophageal ulceration formation. These trends may include: Distance between esophagus and pulmonary vein in patients who developed post-ablation esophageal ulcerations Intra-procedure esophageal temperatures in patients who developed post-ablation esophageal ulcerations Intra-procedure cryoballoon temperatures in patients who developed post-ablation esophageal ulcerations
    Time Frame
    90 days or when complications resolve
    Title
    Assessment of additional Adverse Events
    Description
    To associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations.
    Time Frame
    90 days or when complications resolve
    Secondary Outcome Measure Information:
    Title
    Data collection on Phrenic Injury
    Description
    Assess participants with abnormal imaging and/or adverse events that are related to the treatment.
    Time Frame
    90 days or when complications resolve

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Recurrent, symptomatic, drug-refractory, paroxysmal atrial fibrillation with planned cryoballoon pulmonary vein isolation Age >18 years Planned AF cryoablation procedure Exclusion Criteria: LA diameter >55mm Severe LVH (LV wall ≥ 15mm) LA thrombus Decompensated heart failure Plans for left atrial ablation lesions beyond isolation of the pulmonary veins History of previous pulmonary vein isolation Inability to place esophageal temperature probe or TEE probe Previously documented phrenic nerve injury Known esophageal pathology (complete GI history worksheet)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brian Deville, MD
    Organizational Affiliation
    The Heart Hospital Baylor of Plano
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects

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