ClinicalTrials.gg
RecruitingNCT06716021ReVeRA-301Updated Nov 12, 2026

ReVeRA-301: Etripamil in Atrial Fibrillation Phase 3

A Phase 3 interventional study of Placebo and Etripamil in Atrial Fibrillation, sponsored by Milestone Pharmaceuticals Inc.. Recruiting at 23 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Milestone Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Nov 12, 202614 sites added2 sites removedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 255 studies in Atrial Fibrillation with a site in Netherlands — 33 open to participants now, 49 under way, 2 of them phase 3. Atrial Fibrillation · Netherlands.

Planned enrollment
48th of 192
750 · median 250
Started
2026
with 4 others
Phase 3
31 of 255
1 open now
Primary completion
2028-12
later than 36 of 48 live
Registered
237th of 255
by date

Among the 255 studies in Atrial Fibrillation with a site in Netherlands, this one is the 48th largest by planned enrollment of the 192 interventional ones that give a count, is one of 5 that started in 2026, is one of 31 in phase 3, reaches primary completion later than 36 of the 48 other live ones, and was the 237th registered.

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.

Browse Atrial Fibrillation studies →

Open to participants now

33 of the 255 studies in Atrial Fibrillation with a site in Netherlands are open now. Recruiting first, the newest first:

27 more — sign in →

All 33 open studies →

A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →

Who these studies take

Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 255 studies in Atrial Fibrillation with a site in Netherlands, or all of them as a file.
02

Study summary

This is a multi-national, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil NS in patients with atrial fibrillation (AF). This study includes Screening Visit, Randomization Visit, a Treatment Period with scheduled Follow-up Visits (Monthly Follow-up and Post-treatment Follow-up Visits), a Final Study Visit, and an End of Study Telephone Follow up Visit.

Each patient will be randomized 1:1 to receive placebo or 70 mg Etripamil NS regimens. Patients will self-administer study drug for a perceived episode of AF with RVR with an initial dose of placebo or 70 mg etripamil NS, followed by an optional second dose of the same study drug 10 minutes after the first dose if the patient continues to experience symptoms. Patients may treat up to a maximum of 4 episodes in the study.

Informed consent will be obtained prior to any study procedures.

Read the detailed description

This is a multi-national, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil NS in patients with AF. This study includes a Screening Visit, Randomization Visit, Treatment Period with Follow-up Visits (Monthly Follow-up Visits, and Post-treatment Follow-up Visits), a Final Study Visit, and an End of Study Telephone Follow-up Visit.

Each patient will be randomized in a 1:1 ratio to receive Placebo or 70 mg Etripamil NS regimens. Patients will self-administer study drug for a perceived episode of AF with RVR as follows: an initial dose of placebo or 70 mg etripamil NS, followed by an optional second dose 10 minutes after the first dose if the patient continues to experience symptoms.

Patients may treat up to a maximum of 4 episodes in the study. Informed consent must be obtained prior to any study procedures.

Screening Visit:

Patients with a history of symptomatic AF with RVR will be selected by the Investigator. The screening procedures will include obtaining informed consent, a review of inclusion/exclusion criteria, vital signs, a physical examination, measuring height and weight, screening lab tests, 12-lead electrocardiogram (ECG), recording demographics and medical history and recording of any concomitant medications.

Documentation of AF with RVR, and other data if relevant or requested (e.g. concomitant medications, medical history) will be submitted for Sponsor medical review to confirm and approve patient eligibility for randomization.

Randomization Visit:

Patients eligible for randomization will return to the site to confirm eligibility, record any changes in concomitant medications and adverse events (AEs), and receive training in study procedures including recognizing the presence of customary symptoms of AF, use of the ECG cardiac monitoring system (CMS) device, and electronic patient reported outcome (ePRO) device. Patients will then be randomized 1:1 to placebo or etripamil NS and dispensed study drug kits.

Treatment Period:

When randomized patients identify symptoms of an episode of AF with RVR, they will perform a sequence of steps, including affixing an ECG CMS device, confirming they have an elevated ventricular rate (≥110 bpm), self-administering study drug, and completing an ePRO at specified times post-study drug. A caregiver may help the patient with these procedures. Administration of the study drug regimen during an AF episode is as follows: an initial dose of study drug followed by an optional second dose 10 minutes after the first dose if symptoms persist.

Patients should refrain from additional treatment for their AF with RVR until 45 minutes after their first dose of study drug, after which they should treat their episode as needed per physician-recommended standards of care.

A patient may treat up to 4 episodes during the study.

Follow-up Visits:

Monthly Follow-up Visits Follow-up Visits will occur approximately monthly from the time of randomization until the patient completes the study. These visits will be conducted via site visit or telephone. AEs and concomitant medications therapies will be collected and recorded, continued patient eligibility will be assessed based on information collected, and any re-training on study procedures will be conducted.

Post-treatment Follow-up Visit(s) A Post-treatment Follow-up Visit will occur at the study site within 14 days after a patient administers study drug during the Treatment Period. Up to 4 treated episodes of perceived AF are allowed per patient. AEs and concomitant medications will be collected and recorded, weight and vital signs will be measured, the CMS report from the treated episode will be reviewed, patient eligibility confirmed, study drug kits will be collected for drug accountability, and if applicable the patient will be re-randomized and additional study drug kits dispensed. A focused physical examination will also be performed if needed to assist in the evaluation of any reported AEs.

Details on any medical interventions (e.g. oral medication, intravenous [IV] medication, visits to the emergency department or health-care facility, and/or arrhythmia-related procedure [such as cardioversion]) associated with the treated episode will be collected.

If a patient has completed or will not be continuing in the study, Final Study Visit procedures will be performed.

Final Study Visit:

A Final Study Visit will occur at the study site after a patient administers study drug for the final time during the Treatment Period, or if the patient has completed participation in the study for any other reason. This Visit may be conducted at the same time as a Post-treatment Follow-up Visit.

AEs and concomitant medications will be collected and recorded, weight and vital signs will be measured, the CMS report from the treated episode will be reviewed. A focused physical examination will also be performed if needed to assist in the evaluation of any reported AEs. Reasons for study completion or withdrawal will be collected, and the patient will return the ECG monitoring device and ePRO device at this visit. Study drug kits, ECG CMS devices, and ePRO will be collected.

End of Study Telephone Follow-Up Visit:

An End of Study Telephone Follow-Up Visit will be completed approximately 30 days after the Final Study Visit to follow-up on any ongoing AEs. This visit is not required for patients who did not use the study drug within 30 days before their Final Study Visit.

03

Conditions studied

  • Atrial Fibrillation

Browse trials for

Keywords

  • Atrial Fibrillation
  • Rapid Ventricular Rate
  • Rapid Ventricular Response
  • Ventricular Rate Control
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 years and over.
  2. Provision of written .
  3. Documented history of symptomatic AF (paroxysmal, persistent, or permanent) with a ventricular rate of ≥110 bpm.

    • Documentation: (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 must have a negative pregnancy test at Screening and agree to use at least 1 highly effective form of 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

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) (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 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 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 syndrome.
  8. History of stroke, 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 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.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
750 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Patients will self-administer an initial dose of placebo for a perceived episode of AF with RVR, followed by an optional second dose 10 minutes later if symptoms persist.

    Drug: Placebo

  • Experimental
    Etripamil

    Patients will self-administer an initial dose of etripamil for a perceived episode of AF with RVR, followed by an optional second dose 10 minutes later if symptoms persist.

    Drug: Etripamil

Interventions

  • DrugPlacebo

    The formulation of placebo will consist of water, sodium acetate, disodium EDTA, and sulfuric acid to reproduce the same pH as the etripamil formulation.

  • The formulation of etripamil is for IN administration and will consist of etripamil, water, acetic acid, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid. The dose of etripamil to be evaluated in this study is 70 mg with an optional second dose of 70 mg 10 minutes after the first dose if symptoms persist.

    Also known as: MSP-2017

06

What researchers measure

Primary outcomes

  1. Demonstrate the efficacy of etripamil NS over placebo in patients with AF.

    The maximum reduction in ventricular rate, measured from ECG CMS recordings, within 30 minutes from first drug administration

    Time frame: 30 minutes from first drug administration

07

Study locations

23 of 23 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Dec 2028, 28 months after the start.

Of 62 non-industry phase 3 interventional studies under Atrial Fibrillation, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 73. This study's planned 28 months is below that.

Counting every sponsor, half of 83 studies reached it within 42 months; a quarter within 32 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2024
First posted
Dec 4, 2024
StartActual
Aug 20, 2026
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2029
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
14 sites added, 2 sites removed
Show 14 added (8 Netherlands, 5 United States, 1 Canada)
  • Gelre Ziekenhuizen · Apeldoorn, Netherlands
  • Jeroen Bosch Ziekenhuis · 's-Hertogenbosch, Netherlands
  • Elkerliek Ziekenhuis · Helmond, Netherlands
  • Van Weel-Bethesda Ziekenhuis · Dirksland, Netherlands
  • Blue Coast Research Center, LLC · Vista, United States
  • St Luke's Regional Medical Center, Ltd · Boise, United States
  • TidalHealth Peninsula Regional, Inc · Salisbury, United States
  • Cardiology Consultants of Philadelphia (CCP) · Yardley, United States
  • The Jackson Clinic, PA · Jackson, United States
  • CardioVasc HR Inc · Saint-Jean-sur-Richelieu, Canada
  • Gelderse Vallei Ziekenhuis · Ede, Netherlands
  • Amphia Ziekenhuis · Breda, Netherlands
  • ZGT · Hengelo, Netherlands
  • Frisius Medisch Centrum · Leeuwarden, Netherlands
Show 2 removed
  • ZGT · Almelo, Netherlands
  • Frisius Medisch Centrum · Friesland, Netherlands
across 2 updates, Oct 7, 2026 – Nov 12, 2026
Show all 2 updates
  1. Nov 12, 2026
    10 sites added, 2 sites removed
    Show 10 added (5 United States, 4 Netherlands, 1 Canada)
    • Blue Coast Research Center, LLC · Vista, United States
    • St Luke's Regional Medical Center, Ltd · Boise, United States
    • TidalHealth Peninsula Regional, Inc · Salisbury, United States
    • Cardiology Consultants of Philadelphia (CCP) · Yardley, United States
    • The Jackson Clinic, PA · Jackson, United States
    • CardioVasc HR Inc · Saint-Jean-sur-Richelieu, Canada
    • Gelderse Vallei Ziekenhuis · Ede, Netherlands
    • Amphia Ziekenhuis · Breda, Netherlands
    • ZGT · Hengelo, Netherlands
    • Frisius Medisch Centrum · Leeuwarden, Netherlands
    Show 2 removed
    • ZGT · Almelo, Netherlands
    • Frisius Medisch Centrum · Friesland, Netherlands
  2. Oct 7, 2026
    4 sites added
    Show 4 added (4 Netherlands)
    • Gelre Ziekenhuizen · Apeldoorn, Netherlands
    • Jeroen Bosch Ziekenhuis · 's-Hertogenbosch, Netherlands
    • Elkerliek Ziekenhuis · Helmond, Netherlands
    • Van Weel-Bethesda Ziekenhuis · Dirksland, Netherlands

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06716021
Lead sponsor
Milestone Pharmaceuticals Inc.
Responsible party
Sponsor
First posted
Dec 4, 2024
Start date
Aug 20, 2026
Primary completion
Dec 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Nov 12, 2026

Study contacts

Leonid Kokovin-Sher
Contact
lkokovin-sher@milestonepharma.com
450-912-6783
Silvia Shardonofsky, MD
Contact
sshardonofsky@milestonepharma.com
450-912-6777
James E. Ip, MD
principal investigator · Weill Medical College of Cornell University

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Etripamil

Start the discussion