A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation
NCT ID: NCT05324540
Last Updated: 2022-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2022-04-30
2023-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Cool therapy
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.
Cool therapy
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.
Interventions
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Cool therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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MediCool Technologies
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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FIH-001
Identifier Type: -
Identifier Source: org_study_id
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