A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation (NAPC)
Primary Purpose
Atrial Fibrillation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cool therapy
Sponsored by
About this trial
This is an interventional basic science trial for Atrial Fibrillation
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cool therapy
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05324540
Brief Title
A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation
Acronym
NAPC
Official Title
A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MediCool Technologies
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
An assessment of the use of cold therapy to terminate atrial fibrillation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cool therapy
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Cool therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Termination of atrial fibrillation
Description
Number of successful terminations of atrial fibrillation to normal sinus rhythm upon application of cool therapy will be measured and assessed.
Time Frame
Termination will be measured within 3 minutes of application of cool therapy. No longer term data will be collected.
Secondary Outcome Measure Information:
Title
Time to termination
Description
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 Frame
Time to termination will be assessed only during each application. No longer term data will be collected.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeff Rynbrandt
Phone
231.645.2665
Email
info@medicooltech.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation
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