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

Atrial Fibrillation Clinical Trial

— NAPC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05324540
• Other study ID #: FIH-001
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation

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.