CClinicalTrials.gg
Status unknownNCT05324540NAPCUpdated Apr 12, 2022

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

An interventional study of Cool therapy in Atrial Fibrillation, sponsored by MediCool Technologies. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-12.

Sponsored by MediCool Technologies · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 30 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

This is the only study on the registry with MediCool Technologies as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • OtherCool 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.

06

What researchers measure

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.

    Time frame: 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

    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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05324540
Lead sponsor
MediCool Technologies
Responsible party
Sponsor
First posted
Apr 12, 2022
Start date
Apr 2022 (estimated)
Primary completion
Jun 2022 (estimated)
Completion
Mar 2023 (estimated)
Last update
Apr 12, 2022

Study contacts

Jeff Rynbrandt
Contact
info@medicooltech.com
231.645.2665

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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