Atrial FibrillationNAPCNCT05324540
A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation
A study testing Cool therapy in people with Atrial Fibrillation, run by MediCool Technologies.
Trial summary
An assessment of the use of cold therapy to terminate atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cool therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
An assessment of the use of cold therapy to terminate atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- Cool therapy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cool therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cool therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Time to termination will be assessed only during each application. No longer term data will be collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediCool Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324540
- Sponsor's protocol ID
- FIH-001
- Acronym
- NAPC
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human Evaluation of a Novel Approach to Painless Cardioversion (NAPC) in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05324540
- Acronym / sponsor ID
- NAPC / FIH-001
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MediCool TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Apr 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An assessment of the use of cold therapy to terminate atrial fibrillation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cool therapy | Experimental | Other: Cool therapyA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cool therapyApplication of cool therapy. A chilled (between 5C and 10C) instrument will be applied to the oblique sinus while the patient is in atrial fibrillation. | Other | Cool therapy |
Primary outcome
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.
1 secondary outcome
Time to termination
Time frame: Time to termination will be assessed only during each application. No longer term data will be collected.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Cool therapy in people with Atrial Fibrillation, run by MediCool Technologies.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeff Rynbrandt (231.645.2665, info@medicooltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.