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

MediCool Technologies

Status: Not yet enrolling

Conditions: Atrial Fibrillation

Treatments: Other: Cool therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05324540

FIH-001

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Cool therapy

Experimental group

Description:

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.

Treatment:

Other: Cool therapy