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

NCT05324540 | Unknown DMC

• 1 other identifier: FIH-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to termination

  Time to termination will be assessed only during each application. No longer term data will be collected.

Study Arms (1)

Cool therapy

EXPERIMENTAL

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

Interventions

Cool therapy OTHER

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.

Cool therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MediCool Technologies: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jeff Rynbrandt

CONTACT

231.645.2665; info@medicooltech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 12, 2022
• Study Start: April 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: March 1, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share