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Phase 3 Study of Etripamil Nasal Spray Compared with Placebo in Patients with Atrial Fibrillation and Rapid Ventricular Rate

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people who have Atrial Fibrillation, a common heart rhythm problem where the upper chambers of the heart beat irregularly and often too fast. The treatment being tested is a nasal spray that contains the drug etripamil, which is designed to slow down the heart’s beating speed quickly when given through the nose. The main goal of the trial is to see whether this spray works better than a harmless powder (placebo) in lowering the rapid heart rate caused by the condition.

Participants will receive either the active nasal spray or the harmless powder in a single dose and will be observed for a short period, usually about half an hour, during which their heart’s speed is measured using a simple test that records the heart’s electrical activity (an ECG). They will also answer brief electronic questions (ePRO) about how they feel. Throughout the visit, safety checks such as checking blood pressure and looking for any side effects will be performed. The study follows a straightforward schedule: screening, a single treatment visit, and a short follow‑up period to collect the needed information.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and assignment
After joining the study you are randomly assigned to receive either etripamil nasal spray or a matching placebo. the assignment is done by the study staff and you will not know which one you receive.
Step 2
Baseline measurements
Before the first dose, basic measurements are taken, including an ecg (electrocardiogram) to record heart rhythm, vital signs such as blood pressure and pulse, and a brief symptom rating using a simple questionnaire.
Step 3
First dose administration
You receive a single intranasal spray containing 140 mg of etripamil (or the identical‑appearing placebo). the spray is placed into one nostril as instructed by the study staff. this is the only dose given during the visit.
Step 4
Initial monitoring period
Immediately after the spray, continuous ecg monitoring is performed for at least 30 minutes to track changes in heart rate.
Your vital signs are checked regularly during this time.
Step 5
Symptom questionnaire at 30 minutes
30 minutes after the dose, you complete an electronic symptom questionnaire that uses a 7‑point scale to rate how you feel.
Step 6
Symptom questionnaire at 45 minutes
45 minutes after the dose, a second symptom questionnaire is completed to assess any further changes.
Step 7
Extended monitoring
Additional heart‑rate and safety observations are recorded at 15, 45, 60, 90, 120, 150, 180, 240, and 300 minutes after the dose.
Vital signs and any adverse events are noted at each time point.
Step 8
Final assessment
At the end of the monitoring period, the study staff reviews all heart‑rate data, symptom scores, and safety information.
You are asked about any side effects or concerns that occurred during the visit.
Step 9
Study completion
After the final assessment, your participation in this visit is concluded.
No further study medication is taken during this visit.

Who can join the trial?

7 criteria

Be 18 years of age or older.
Sign a written informed consent, which means you agree in writing after the study has been explained to you.
Have a documented history of symptomatic atrial fibrillation (irregular heart rhythm) with a fast heart rate (called a ventricular rate) of at least 110 beats per minute.
Have experienced at least two episodes of atrial fibrillation in the past 12 months that lasted 20 minutes or longer, caused symptoms, and were accompanied by a fast heart rate.
Be taking appropriate blood‑thinning medication (antithrombotic/anticoagulation therapy) as recommended for managing atrial fibrillation.
If you are a woman who could become pregnant, you must have a negative pregnancy test at screening, use at least one highly effective method of birth control from the time you are randomized until 7 days after the last dose of the study drug, and agree to stop the study if you become or plan to become pregnant.
Be willing and able to follow the study schedule, take the treatment as directed, and attend all required visits and procedures.

Who cannot join the trial?

16 criteria

Having a primary diagnosis of atrial flutter (a fast rhythm that starts in the upper chambers of the heart) or atrial tachycardia (another type of fast heart rhythm). Patients who have atrial fibrillation together with flutter in the same episode are allowed.
Planning to have an ablation procedure for atrial fibrillation or for the atrioventricular (AV) node within the next three months. (Ablation is a treatment that destroys small areas of heart tissue that cause abnormal rhythms.)
Having severe narrowing (stenosis) of the aortic or mitral heart valves that has not been treated.
Having hypertrophic cardiomyopathy (a condition where the heart muscle is unusually thick) that blocks the pathway for blood to leave the heart (outflow tract obstruction).
Being allergic (having a sensitivity) to the medication verapamil or to any ingredient in the study spray.
Having a recent or ongoing problem with chronic alcohol or drug abuse that could affect the study results.
Currently taking part in another drug or device study, or having received an experimental drug or device within 30 days before the screening visit.
Having any other important health problem that could make it hard to follow the study plan or could affect the study’s outcomes.
Having any of the following in the past six months: severe chest pain called angina (Class 3 or 4 on the Canadian Cardiovascular Society scale), chest pain that occurs during atrial fibrillation episodes, an acute coronary syndrome event (such as a heart attack) unless the blocked artery was successfully opened (re‑vascularized), or major heart surgery like coronary artery bypass grafting or open‑chest valve surgery.
Having a recent episode (within the last three months) of heart failure that is classified as New York Heart Association (NYHA) Class III or higher (meaning marked limitation of physical activity).
Having experienced unstable blood flow during atrial fibrillation, such as very low blood pressure (hypotension) or fainting (syncope) caused by a pause when the rhythm changes.
Having a history of unexplained fainting (syncope).
Having a history or an ECG showing any of the following without a pacemaker: sick sinus syndrome (the heart’s natural pacemaker doesn’t work well), Mobitz II second‑ or third‑degree atrioventricular block (a serious interruption in the heart’s electrical signal), a very slow heart rate (bradycardia under 40 beats per minute), or pauses longer than three seconds while awake.
Having a history or ECG evidence of dangerous heart rhythm problems such as torsades de pointes, ventricular fibrillation, ventricular tachycardia, Brugada syndrome, an extra electrical pathway like Wolff‑Parkinson‑White or Lown‑Ganong‑Levine syndromes, or a prolonged QT interval (long QT syndrome).
Having had a stroke, a transient ischemic attack (a brief “mini‑stroke”), or a blockage of a blood vessel outside the brain (peripheral embolism) within the last three months.
Having a CHA2DS2‑VASc score greater than 5 (a scoring system that estimates the risk of stroke in people with atrial fibrillation; a higher score means higher risk).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amphia Hospital
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Breda, The Netherlands
Frisius
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Heerenveen, The Netherlands
Gelre Hospitals
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Zutphen, The Netherlands

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Investigated drugs

Etripamil is a medication delivered as a nasal spray that is placed into the nose. In this study, it is being tested to see if it can quickly slow down the heart rhythm in people who have atrial fibrillation with a fast heartbeat. The spray is intended to act fast, helping to bring the heart rate back to a normal range without needing an injection or oral pills.

Etripamil

What is already known about the treatment

Etripamil
Etripamil is supplied as a nasal spray that is sprayed into the nose for quick absorption. It is currently being studied in a Phase 3 trial and is not yet approved for general medical use. The spray is intended to help people with atrial fibrillation who have a fast heart rate by slowing the heart’s rhythm. It works by briefly blocking calcium channels in heart cells, which reduces the electrical signals that make the heart beat too fast, and it is classified as a short‑acting calcium‑channel blocker (anti‑arrhythmic).
Placebo for etripamil nasal spray
The placebo is a nasal spray that contains no active drug and is used only as a control in the study. It has no therapeutic effect and is not a medication that is marketed or approved for any condition. Its purpose is to mimic the appearance and feel of the etripamil spray so that participants and investigators can compare outcomes fairly. As an inert comparator, it does not have a pharmacological class or mechanism of action.

Investigated diseases

Atrial Fibrillation - Atrial fibrillation is an irregular and often rapid heart rhythm that starts in the upper chambers of the heart. The condition causes the atria to beat chaotically, leading to an uneven pulse. Over time, the irregular rhythm may become more frequent or last longer, sometimes changing from occasional episodes to a persistent pattern. The heart may have difficulty maintaining a steady rate, which can produce sensations such as palpitations, shortness of breath, or fatigue. In some individuals, the abnormal rhythm can spread to the lower chambers, affecting overall heart function.