Nasal spray could tame racing heart in AFib patients
NCT ID NCT06716021
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times
Summary
This study tests an investigational nasal spray called etripamil for people with atrial fibrillation (AFib) who experience episodes of dangerously fast heart rate. About 750 adults will be randomly assigned to use either the real spray or a placebo at home when symptoms start. The goal is to see if the spray can quickly lower heart rate within 30 minutes, potentially offering a convenient way to manage sudden episodes without a trip to the hospital.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 750 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 years and over. 2. Provision of written informed consent. 3. Documented history of symptomatic AF (paroxysmal, persistent, or permanent) with a ventricular rate of ≥110 bpm. * Documentation: electrocardiogram (ECG) tracing (including 12-lead ECG or ECG strip) showing AF with ventricular rate ≥110 beats per minute (bpm). This ECG documentation (anonymized with study Patient ID only) will be submitted to the Sponsor after screening and prior to randomization to confirm diagnosis of AF with RVR and eligibility to be randomized in the study. Patients who have undergone a prior ablation procedure for AF or for an AF-trigger must have documented AF with RVR post-ablation for study eligibility. 4. Documented history of repeated (at least 2 within the prior 12 months) and prolonged (at least 20 minutes) symptomatic episodes of AF with elevated (perceived or measured) heart rate (HR). * Documentation: Patient description, other history, or medical records. Patients who have undergone a prior ablation procedure for AF or for an AF-trigger must fulfill this criterion post-ablation for study eligibility. 5. Receiving appropriate antithrombotic/anticoagulation therapy as per applicable national and/or local guidelines for AF management. 6. Women of childbearing potential must have a negative pregnancy test at Screening and agree to use at least 1 highly effective form of contraception from time of randomization until 7 days after the last administration of study drug and must be willing to discontinue from the study should they become or plan to become pregnant. Exclusion Criteria: 1. Patients with a primary diagnosis of atrial flutter (typical or atypical) or atrial tachycardia. Patients with AF who have been observed to also experience atrial flutter within the same episode (i.e., "AFib/Flutter" or an admixture of AF and flutter within the same episode) are eligible. 2. History of any of the following within the last 6 months: Class 3 or 4 angina per Canadian Cardiovascular Society (CCS) criteria; ischemic chest pain during AF episodes; acute coronary syndrome, unless the patient has been successfully revascularized; coronary artery bypass grafting or open-chest valve surgery. 3. History of heart failure (HF) New York Heart Association (NYHA) classification ≥Class III within the last 3 months. * The etiology of any HF should have been previously evaluated and addressed. * HF with a reduced ejection fraction and/or HF with a preserved ejection fraction are acceptable. 4. History of hemodynamic instability during AF, i.e., symptoms or signs of severe hypotension, or syncope due to a pause upon conversion from AF to sinus rhythm (SR). 5. History of unexplained syncope. 6. History of, or ECG evidence at the screening visit, of: sick sinus syndrome, Mobitz II second- or third-degree atrioventricular (AV) block bradycardia (\<40 bpm) or pauses \>3 seconds during waking hours, without a pacemaker. 7. History of, or ECG evidence at the Screening visit, of: torsades de pointes, ventricular fibrillation, or ventricular tachycardia, Brugada syndrome, an antegrade conducting accessory bypass tract (e.g., Wolff-Parkinson-White or Lown-Ganong-Levine syndromes), or long QT syndrome. 8. History of stroke, transient ischemic attack or peripheral embolism within the last 3 months. 9. CHA2DS2-VASc score of \>5. 10. Planned AF or AV node ablation within the next 3 months. 11. Uncorrected, severe aortic or mitral stenosis. 12. Hypertrophic cardiomyopathy with outflow tract obstruction. 13. History of sensitivity to verapamil or to any components of the investigational product. 14. History of recent or current chronic alcohol or drug abuse that, in the opinion of the Investigator, could impact the validity of the study results. 15. Currently participating in another drug or device study, or has received an investigational drug or device within 30 days prior to Screening. 16. Any other significant co-morbid condition that may negatively impact the patient's participation in the study or likely result in non-compliance.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cardiovascular Associates Of The Delaware Valley
RECRUITINGHaddon Heights, New Jersey, 08035, United States
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Montreal Heart Institute
RECRUITINGMontreal, Quebec, H1T1C8, Canada
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Weill Cornell Medicine
RECRUITINGManhattan, New York, 10065, United States
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Other studies related to the condition(s) this trial covers.
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