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

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

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Cool therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cool therapy<br>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. | Other: Cool therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Termination will be measured within 3 minutes of application of cool therapy. No longer term data will be collected. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Time to termination will be assessed only during each application. No longer term data will be collected. |