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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Other: Cool therapy

• Registration Number: NCT05324540
• Lead Sponsor: MediCool Technologies

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-18
• Study Start: 2022-04
• Study First Submitted QC: 2022-04-05
• Last Update Submitted: 2022-04-05
• Study First Posted: 2022-04-12
• Last Update Posted: 2022-04-12
• Primary Completion: 2022-06
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 year

Exclusion 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cool therapy	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.

Primary Outcome Measures

Name	Time	Method
Termination of atrial fibrillation	Termination will be measured within 3 minutes of application of cool therapy. No longer term data will be collected.	Number of successful terminations of atrial fibrillation to normal sinus rhythm upon application of cool therapy will be measured and assessed.

Secondary Outcome Measures

Name	Time	Method
Time to termination	Time to termination will be assessed only during each application. No longer term data will be collected.	The time it takes (in minutes and seconds) to terminate atrial fibrillation to normal sinus rhythm will be measured following application of cool therapy.