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

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

14 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.
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.

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

MediCool Technologies

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.

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