Atrial Fibrillation study: Etripamil
Official title ReVeRA-301: Etripamil in Atrial Fibrillation Phase 3
ClinicalTrials.gov ID: NCT06716021
What this study is testing
What is Etripamil?
An investigational intranasal medication being studied for the treatment of atrial fibrillation.
Also referred to as MSP-2017.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how well etripamil NS works compared with a placebo for stopping rapid heart rhythm episodes in people with atrial fibrillation.
- Who it's for
- Adults who have atrial fibrillation and experience rapid heart rhythm episodes.
- What's involved
- Participants will take the study drug by mouth when they feel an episode of rapid heart rhythm. They may take a second dose 10 minutes later if symptoms continue, and can treat up to four episodes during the study. They will attend scheduled visits for screening, randomization, monthly follow‑ups, a final visit, and a telephone follow‑up.
- Time commitment
- The study lasts about several months, with visits at screening, randomization, monthly follow‑ups, a final visit, and a telephone call after the study ends.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years and over.
- Provision of written informed consent.
- 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).
- Documented history of repeated (at least 2 within the prior 12 months) and prolonged (at least 20 minutes) symptomatic episodes of AF with elevated...
You likely can't join if
- Patients with a primary diagnosis of atrial flutter (typical or atypical) or atrial tachycardia.
- History of any of the following within the last 6 months: Class 3 or 4 angina per Canadian Cardiovascular Society (CCS) criteria
- 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.
- 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...
See the full eligibility criteria
- Age 18 years and over.
- Provision of written informed consent.
- 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).
- 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.
- Receiving appropriate antithrombotic/anticoagulation therapy as per applicable national and/or local guidelines for AF management.
- 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...
- 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...
- 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
- 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.
- 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).
- History of unexplained syncope.
- History of, or ECG evidence at the screening visit, of: sick sinus syndrome, Mobitz II second- or third-degree atrioventricular (AV) block bradycardia (\ 3 seconds during waking hours, without a pacemaker.
- 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...
- History of stroke, transient ischemic attack or peripheral embolism within the last 3 months.
- CHA2DS2-VASc score of \>5.
- Planned AF or AV node ablation within the next 3 months.
- Uncorrected, severe aortic or mitral stenosis.
- Hypertrophic cardiomyopathy with outflow tract obstruction.
- History of sensitivity to verapamil or to any components of the investigational product.
- 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.
- Currently participating in another drug or device study, or has received an investigational drug or device within 30 days prior to Screening.
- Any other significant co-morbid condition that may negatively impact the patient's participation in the study or likely result in non-compliance.
The study team makes the final eligibility decision.
Where it is enrolling
- Vista, California, United States
- West Hills, California, United States
- Littleton, Colorado, United States
- Boise, Idaho, United States
- Salisbury, Maryland, United States
- Haddon Heights, New Jersey, United States
- Manhattan, New York, United States
- Yardley, Pennsylvania, United States
- Jackson, Tennessee, United States
- Montreal, Quebec, Canada
- Saint-Jean-sur-Richelieu, Quebec, Canada
- Apeldoorn, Gelderland, Netherlands
- Arnhem, Gelderland, Netherlands
- Ede, Gelderland, Netherlands
- 's-Hertogenbosch, North Brabant, Netherlands
- Breda, North Brabant, Netherlands
- Helmond, North Brabant, Netherlands
- Roosendaal, North Brabant, Netherlands
- Alkmaar, North Holland, Netherlands
- Hengelo, Overijssel, Netherlands
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Vista, California, United States; West Hills, California, United States; Littleton, Colorado, United States; Boise, Idaho, United States; Salisbury, Maryland, United States; Haddon Heights, New Jersey, United States and 17 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.