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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05324540
Other study ID # FIH-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2022
Est. completion date March 2023

Study information

Verified date March 2022
Source MediCool Technologies
Contact Jeff Rynbrandt
Phone 231.645.2665
Email info@medicooltech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date March 2023
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
MediCool Technologies

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
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