- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05324540
A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation (NAPC)
April 5, 2022 updated by: MediCool Technologies
An assessment of the use of cold therapy to terminate atrial fibrillation.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jeff Rynbrandt
- Phone Number: 231.645.2665
- Email: info@medicooltech.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cool therapy
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Termination of atrial fibrillation
Time Frame: Termination will be measured within 3 minutes of application of cool therapy. No longer term data will be collected.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to termination
Time Frame: Time to termination will be assessed only during each application. No longer term data will be collected.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2022
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
March 1, 2023
Study Registration Dates
First Submitted
March 18, 2022
First Submitted That Met QC Criteria
April 5, 2022
First Posted (Actual)
April 12, 2022
Study Record Updates
Last Update Posted (Actual)
April 12, 2022
Last Update Submitted That Met QC Criteria
April 5, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIH-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
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Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
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Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
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R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
Clinical Trials on Cool therapy
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Abbott Medical DevicesCompletedTypical Atrial FlutterUnited States, Canada
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Abbott Medical DevicesCompletedParoxysmal Atrial FibrillationAustralia, Germany, France, Italy, Portugal, United Kingdom
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Abbott Medical DevicesCompletedTypical Atrial FlutterUnited States, Canada
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Abbott Medical DevicesCompletedTypical Atrial FlutterUnited States, Canada
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The David Hide Asthma & Allergy Research CentreIsle of Wight NHS TrustCompleted
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University of MinnesotaCompletedMulticomponent School Based Behavioral Intervention | Prevent Further Weight Gain and or Promote | Weight Loss Among Adolescents
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Olympic MedicalCompletedNeonatal Hypoxic-Ischemic Encephalopathy (HIE)United States, Canada, United Kingdom, New Zealand
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Medical University of South CarolinaCompletedVenous InsufficiencyUnited States
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Region of Southern DenmarkCompletedAnxiety Disorder