Abnormal heart rhythm arrhythmia
Conditions
Interventions
1 Group of patients will receive a single dose of intranasal admnistration of
etripamil 70 mg, while the other group will receive placebo.
Sponsors
Milestone Pharmaceuticals
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and over 2. Has provided written informed consent 3. Patients with episodes of paroxysmal, persistent or permanent AF, presenting with AF and a ventricular rate >=110 bpm, measured over 1 minute on an ECG 4. Patients should receive appropriate antithrombotic therapy as per Canadian Cardiovascular Society (CCS) guidelines. a. Etripamil (a calcium channel blocker) is intended for acute rate control only. If rhythm control is desired (outside of the present protocol), anticoagulation as per CCS guidelines may start after the administration of study drug.
Exclusion criteria
Exclusion criteria: 1. Has evidence of atrial flutter (ECG) at presentation 2. Has a history of stroke, transient ischemic attack, or peripheral embolism within the last 3 months 3. Has received by IV route any of the following within one hour before study drug administration: flecainide, procainamide, digoxin, beta-blocker, or calcium chanel blocker 4. Has signs and symptoms of severe congestive heart failure at presentation (e.g. tachypnea, oxygen desaturation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to demonstrate the superiority of etripamil NS over placebo in reducing ventricular rate in patients with AF. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to evaluate the safety and efficacy of etripamil NS in patients with AF. | — |
Countries
Netherlands
Outcome results
None listed