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A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation (NAPC)

Primary Purpose

Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cool therapy
Sponsored by
MediCool Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atrial Fibrillation

Eligibility Criteria

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

Inclusion Criteria:

  • Subject must be ≥ 18 years or older
  • Male of female
  • Subject has documented paroxysmal, or persistent atrial fibrillation (AF) with a history of less than one-year duration
  • Must be in AF at time of surgery, or inducible using manual or electrical stimulation
  • Subject is willing and able to provide written informed consent
  • Subject has a life expectancy of at least 1 yearExclusion Criteria:

Exclusion Criteria: • Long-standing AF (duration > 1 year)

  • Prior AF ablation
  • Left main coronary artery occlusion > 70%
  • Critical aortic stenosis (gradient > 50mm HG)
  • Inability to induce patient into AF without drugs at time of surgery
  • Female subjects who are pregnant at time of surgery
  • Subjects with a medical condition or comorbidity that could adversely impact study participation, safety or conduct of the study
  • Permanent pacemaker or implantable cardioverter defibrillator
  • Current cancer treatment that includes radiation of the heart
  • Inability to give informed consent
  • Significant intra-cardiac thrombus
  • Subjects not eligible for or considered high risk for anticoagulation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cool therapy

    Arm Description

    A chilled instrument that has been chilled to a proscribed temperature will be applied to the oblique sinus. The instrument may be applied for up to 3 minutes per application and up to 3 times per patient.

    Outcomes

    Primary Outcome Measures

    Termination of atrial fibrillation
    Number of successful terminations of atrial fibrillation to normal sinus rhythm upon application of cool therapy will be measured and assessed.

    Secondary Outcome Measures

    Time to termination
    The time it takes (in minutes and seconds) to terminate atrial fibrillation to normal sinus rhythm will be measured following application of cool therapy.

    Full Information

    First Posted
    March 18, 2022
    Last Updated
    April 5, 2022
    Sponsor
    MediCool Technologies
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05324540
    Brief Title
    A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation
    Acronym
    NAPC
    Official Title
    A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2022 (Anticipated)
    Primary Completion Date
    June 2022 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    MediCool Technologies

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    An assessment of the use of cold therapy to terminate atrial fibrillation.

    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
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cool therapy
    Arm Type
    Experimental
    Arm Description
    A chilled instrument that has been chilled to a proscribed temperature will be applied to the oblique sinus. The instrument may be applied for up to 3 minutes per application and up to 3 times per patient.
    Intervention Type
    Other
    Intervention Name(s)
    Cool therapy
    Intervention Description
    Application of cool therapy. A chilled (between 5C and 10C) instrument will be applied to the oblique sinus while the patient is in atrial fibrillation.
    Primary Outcome Measure Information:
    Title
    Termination of atrial fibrillation
    Description
    Number of successful terminations of atrial fibrillation to normal sinus rhythm upon application of cool therapy will be measured and assessed.
    Time Frame
    Termination will be measured within 3 minutes of application of cool therapy. No longer term data will be collected.
    Secondary Outcome Measure Information:
    Title
    Time to termination
    Description
    The time it takes (in minutes and seconds) to terminate atrial fibrillation to normal sinus rhythm will be measured following application of cool therapy.
    Time Frame
    Time to termination will be assessed only during each application. No longer term data will be collected.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject must be ≥ 18 years or older Male of female Subject has documented paroxysmal, or persistent atrial fibrillation (AF) with a history of less than one-year duration Must be in AF at time of surgery, or inducible using manual or electrical stimulation Subject is willing and able to provide written informed consent Subject has a life expectancy of at least 1 yearExclusion Criteria: Exclusion Criteria: • Long-standing AF (duration > 1 year) Prior AF ablation Left main coronary artery occlusion > 70% Critical aortic stenosis (gradient > 50mm HG) Inability to induce patient into AF without drugs at time of surgery Female subjects who are pregnant at time of surgery Subjects with a medical condition or comorbidity that could adversely impact study participation, safety or conduct of the study Permanent pacemaker or implantable cardioverter defibrillator Current cancer treatment that includes radiation of the heart Inability to give informed consent Significant intra-cardiac thrombus Subjects not eligible for or considered high risk for anticoagulation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jeff Rynbrandt
    Phone
    231.645.2665
    Email
    info@medicooltech.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation

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