NL-OMON54054已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation to Sinus Rhythm - RESTORE-1
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. >=18 and <=87 years of age
- •2. Ongoing event of newly diagnosed or paroxysmal AF
- •a. Newly diagnosed AF is AF that has not been diagnosed previously.
- •b. Paroxysmal AF is defined as recurrent AF in a patient whose previous AF
- •episode(s) self-terminated (ie, without treatment) or terminated with
- •intervention <=7 days of onset.
- •c. AF must be monitored on cardiac telemetry/monitoring for >=45 minutes prior
- •to randomization (may include monitoring time prior to informed consent)
- •3. Presence of AF-related symptom(s) with a time of onset >=1 and <=48 hours (ie,
- •recent-onset) at the time of randomization. AF-related symptoms are defined as
- •any of the following:
- •a. pitations (pounding, racing or irregular heartbeat)
- •b. Chest pain/pressure
- •c. Dizziness/lightheadedness
- •d. Shortness of breath
排除标准
- •Atrial Fibrillation (AF)/Atrial Flutter (AFL) history
- •1. Most recent pharmacological cardioversion failed to restore SR or >=2
- •previous failed attempts to restore SR with pharmacological cardioversion
- •2. Has had >=4 electrical cardioversion procedures <=1 years prior to screening
- •3. Current diagnosis or prior history of persistent AF
- •a. Persistent AF defined as AF that is continuously sustained >7 days,
- •including episodes terminated by cardioversion (drugs or electrical
- •cardioversion) after >7 days.
- •b. Patients who have undergone an ablation procedure for persistent AF are not
- •4. Cardiac ablation <=28 days prior to screening
- •Vital signs
- •5. Hemodynamic or cardiac instability during the screening period, defined as
- •any of the following:
- •a. Systolic blood pressure (SBP) <100 or >=160 mmHg
- •b. Diastolic blood pressure (DBP) <60 or >=95 mmHg
- •c. Ventricular heart rate (HR) <80 or >160 bpm
- •If any of the above criteria are observed, they must be confirmed by >=3
- •consecutive measurements (ie, assessed >=2 more times) over >=5 minutes to be
- •exclusionary. Failure to perform confirmatory assessments is also exclusionary.
- •6. Uncontrolled hyperventilation (ie, inability to maintain a respiratory rate
- •<=22 breaths per minute prior to randomization)
- •Relevant structural heart disease
- •7. Evidence of significant HF defined as any of the following:
- •a. Hospitalization in the last 12 months for HF or suspected HF event (eg,
- •acute decompensated HF)
- •b. Most recent assessment of left ventricular ejection fraction (LVEF) <45%, if
- •i. For patients in the United States, a standard diagnostic echocardiogram
- •assessed <=180 days prior to screening is required to ascertain eligibility. If
- •none is available, the patient must undergo a standard diagnostic
- •echocardiogram or a diagnostic echocardiogram using a portable ultrasound
- •device (handheld echocardiogram [HHE]) during screening to confirm eligibility.
- •c. New York Heart Association (NYHA) Class III-IV symptoms
- •d. Previous or current evidence of significant left ventricular (LV)
- •hypertrophy in the opinion of the Investigator
- •e. Medication history suggestive of HF per the Investigator's discretion
- •8. Signs or symptoms of ongoing myocardial ischemia, including any of the
- •following observed during screening:
- •a. Significant ST segment elevation or depression (ie, >=2 mm) on a standard
- •12-lead ECG
- •b. Echocardiogram findings (eg, wall motion abnormalities) suggestive of acute
- •myocardial infarction (MI), if an echocardiogram is obtained
- •c. Angina pectoris, atypical angina pectoris, or receiving antianginal
- •medication for ischemia
- •9. History of MI <=3 months of screening
- •10. Current or previous history of uncorrected moderate or severe aortic or
- •mitral valvular stenosis, in the opinion of the Investigator
- •Other CV conditions
- •11. Stroke (including transient ischemic attack) <=3 months prior to
- •randomization
- •12. Known history of any of the following cardiac abnormalities:
- 另有 9 项未显示
研究者
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