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CADENCE
Inclusion Criteria
1. Patients with paroxysmal AF (recent or new onset) duration
defined as 3 hours to ≤ 7-days
(Group 1 only); or patients with persistent AF duration defined as
> 7 up to 30 days (Group 2
only) at the time of randomization. Review of subject medical
records and the judgment of the
principal investigator should be documented to establish the date
of onset and duration of AF.
2. Patients must be hemodynamically stable defined as a
screening systolic blood pressure between
90 to 160 mmHg, diastolic < 100 mmHg.
3. Low risk of thromboembolic potential as documented by
• Subjects with AF lasting < 48 hours (by ECG);
• Subjects with AF duration longer than 48 hours, have had 3weeks of anti-coagulation
Exclusion Criteria
1. History of long QT syndrome, Torsade de Pointes or an
uncorrected QT interval of > 450 ms.
2. QRS interval > 120 ms at Screening.
3. History of myocardial infarction within 6 months of Screening.
4. History of ventricular tachycardia, fibrillation, or resuscitated
cardiac arrest.
5. History of clinically significant congenital heart disease.
6. Part 2: Subjects with a diagnosis of heart failure, ejection
fraction < 35%, as determined by any method within 6 months of
Screening.
7. Current diagnosis of atrial flutter.
GLORIA-AF
Inclusion Criteria
1. Patient newly diagnosed (< 3 months prior to baseline
visit) with non-valvular AF.
Documentation of AF by 12 lead ECG, ECG rhythm strip,
pacemaker/ICD electrocardiogram, or Holter ECG (duration
of AF episode at least 30 seconds) needed for all enrolled
patients.
2. 4. Patient must have a CHA2DS2-VASc score of at least 1.
This requires the presence of at least one of the following
risk factors:
a. Congestive heart failure (NYHA Class 2 or greater) or
moderate to severe LV systolic dysfunction (e.g. LV EF ≤
40%)
b. History of hypertension or systolic blood pressure
>160mmHg
c. Diabetes mellitus
d. History of stroke, transient ischemic attack, or systemic
embolism
e. Vascular disease defined as prior myocardial infarction,
peripheral artery disease, complex aortic plaque
f. Age ≥ 65
g. Female gender
Exclusion Criteria
1. Patients who have received more than 60 days of VKA
treatment in their lifetime prior to the patient’s baseline
visit
2. AF with a generally reversible cause (e.g., cardiac surgery,
pulmonary embolism, untreated hyperthyroidism)
RAID
Inclusion Criteria
1. Secondary or primary prevention patients with ischemic or
nonischemic cardiomyopathy who meet current guidelines for
ICD or CRT-D device therapy and meet the above definition of
high-risk patients.
Exclusion Criteria
1. Patients with preexisting QTc prolongation >550ms
2. Patients on strong CYP3A inhibitors (including ketoconazole,
itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir,
indinavir and saquinavir and moderate CYP3A inhibitors,
including, diltiazem, verapamil, aprepitant, erythromycin,
fluconazole and grapefruit juice or grapefruit-containing
products.