Phase
Condition
Atrial Fibrillation
Arrhythmia
Chest Pain
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- Males and females aged 18 years and older
- Have the ability to understand and sign a written informed consent form, which must beobtained prior to initiation of study procedures
- History of PAF documented within the prior 12 months
- Patients with PAF undergoing cardioversion greater than 4 weeks prior to Screeningare eligible
- Implanted (at least 3 months prior to Screening) dual chamber programmable pacemakerswith AF detection capabilities
- AFB ≥ 1% and ≤ 70% between the last clinic evaluation and Screening (minimum of 1month observation period) and AFB ≥ 2% and ≤ 70% during the Run in period
- Sexually active females of childbearing potential must agree to utilize effectivemethods of contraception during heterosexual intercourse throughout the treatmentperiod and for 14 days following discontinuation of the study medication
Exclusion
Key Exclusion Criteria: Disease - specific:
- Persistent AF or Permanent AF
- History of atrial flutter or atrial tachycardia without successful ablation
- Other acutely reversible causes of AF, including but not limited to: hyperthyroidism,pericarditis, myocarditis, or pulmonary embolism
- New York Heart Association (NYHA) Class III and IV heart failure or NYHA Class IIheart failure with a recent decompensation requiring hospitalization or referral to aspecialized heart failure clinic within 4 weeks prior to Screening.
- Recent history of left ventricular ejection fraction (LVEF) < 40%
- Myocardial infarction, unstable angina, or coronary artery bypass graft (CABG) surgerywithin three months prior to Screening or percutaneous coronary intervention (PCI)within 4 weeks prior to Screening
- Clinically significant valvular disease in the opinion of the Investigator
- Stroke within 3 months prior to Screening
- History of serious ventricular arrhythmias (eg, sustained ventricular tachycardia,ventricular fibrillation) within 4 weeks prior to Screening
- Family history of long QT syndrome
- Corrected QT interval (QTc) ≥ 500 msec (Bazett) at Screening ECG if in sinus rhythm (SR). If in AF, evidence of QTc ≥ 500 msec (Bazett) within 4 weeks prior to Screening
- Prior heart transplant
- Cardiac ablation within 4 months prior to Screening, or planned ablation during thecourse of the study Concomitant medications/food
- Need for concomitant treatment during the trial, with drugs or products that arestrong inhibitors of cytochrome P450 3A (CYP3A), or inducers of CYP3A
- Such medications should be discontinued 5-half lives prior to the Run-in period
- Use of grapefruit juice or Seville orange juice during the study
- Use of Class I and Class III antiarrhythmic drugs other than amiodarone within 5-halflives prior to the Run-in period
- Use of amiodarone within 3 months prior to Screening
- Use of drugs that prolong the QT interval
- Previous use of ranolazine or dronedarone within 2 months prior to screening
- Prior use of ranolazine or dronedarone which was discontinued for safety ortolerability
- Use of dabigatran during the study
- Use of digitalis preparations (eg, digoxin) during the study
- Use of a greater than 1000 mg total daily dose of metformin during the study Laboratory tests:
- Hypokalemia (serum potassium < 3.5 mEq/L) at Screening that cannot be corrected to alevel of potassium ≥ 3.5 mEq/L prior to randomization
- Moderate and severe hepatic impairment (ie, Child-Pugh Class B and C), abnormal liverfunction test defined as alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin > 2 x upper limit of normal (ULN) at Screening
- Severe renal impairment defined as creatinine clearance ≤ 30 mL/min at Screening Others:
- Females who are pregnant or are breastfeeding
- In the judgment of the Investigator, any clinically-significant ongoing medicalcondition that might jeopardize the individual's safety or interfere with the study,including participation in another clinical trial within the previous 30 days using atherapeutic modality which could have potential residual effects that might confoundthe results of this study
- Any device-related technical issue which in the judgment of the investigator woulddisrupt adequate data collection or interpretation (eg, anticipated pulse generatorchange or lead revision) Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Investigational Site
Erlangen, Bayern 91054
GermanySite Not Available
Investigational Site
München, Bayern 81377
GermanySite Not Available
Investigational Site
Weiden, Bayern 92637
GermanySite Not Available
Investigational Site
Würzburg, Bayern 97080
GermanySite Not Available
Investigational Site
Wiesbaden, Hessen 65191
GermanySite Not Available
Investigational Site
Bielefeld, Nordrhein-westfalen 33604
GermanySite Not Available
Investigational Site
Bonn, Nordrhein-westfalen 53105
GermanySite Not Available
Investigational Site
Dortmund, Nordrhein-westfalen 44137
GermanySite Not Available
Investigational Site
Coburg, 96450
GermanySite Not Available
Investigational Site
Frankfurt, 60594
GermanySite Not Available
Investigational Site
Goettingen, 37075
GermanySite Not Available
Investigational Site
Göttingen, 37075
GermanySite Not Available
Investigational Site
Hamburg, 20246
GermanySite Not Available
Investigational Site
Ingolstadt, 85049
GermanySite Not Available
Investigational Site
Lubeck, D23538
GermanySite Not Available
Investigational Site
Ashkelon, Ashqelon 78287
IsraelSite Not Available
Investigational Site
Afula, Zefat 18101
IsraelSite Not Available
Investigational Site
Hadera, 38100
IsraelSite Not Available
Investigational Site
Haifa, 31096
IsraelSite Not Available
Investigational Site
Holon, 58100
IsraelSite Not Available
Investigational Site
Jerusalem, 91031
IsraelSite Not Available
Investigational Site
Nahariya, 22100
IsraelSite Not Available
Investigational Site
Petach Tikva, 49100
IsraelSite Not Available
Investigational Site
Ramat Gan, 52621
IsraelSite Not Available
Investigational Site
Rehovot, 76100
IsraelSite Not Available
Investigational Site
Tel Aviv, 64239
IsraelSite Not Available
Investigational Site
Tel Hashomer, 52621
IsraelSite Not Available
Investigational Site
Bologna, 40138
ItalySite Not Available
Investigational Site
Como, 22020
ItalySite Not Available
Investigational Site
Firenze, 50134
ItalySite Not Available
Investigational Site
Maastricht, Limburg 6229 HX
NetherlandsSite Not Available
Investigational Site
Groningen, 9700 RB
NetherlandsSite Not Available
Investigational Site
Torun, Kujawsko-pomorskie 87-100
PolandSite Not Available
Investigational Site
Lódz, Lodzkie 90-553
PolandSite Not Available
Investigational Site
Lódz, Lodzkie 90-553
PolandSite Not Available
Investigational Site
Kraków, Malopolskie 31-501
PolandSite Not Available
Investigational Site
Kraków, Malopolskie 31-501
PolandSite Not Available
Investigational Site
Warsaw, Mazowieckie 01-211
PolandSite Not Available
Investigational Site
Bialystok, Podlaskie 15-276
PolandSite Not Available
Investigational Site
Gdansk, Pomorskie 80-219
PolandSite Not Available
Investigational Site
Sopot, Pomorskie 81-717
PolandSite Not Available
Investigational Site
Katowice, Slaskie 40-635
PolandSite Not Available
Investigational Site
Zabrze, Slaskie 41-800
PolandSite Not Available
Investigational Site
Posnan, Wielkopolskie 61-848
PolandSite Not Available
Investigational Site
Poznań, Wielkopolskie 61-848
PolandSite Not Available
Investigational Site
Szczecin, Zachodniop 70-203
PolandSite Not Available
Investigational Site
Lodz, 91-425
PolandSite Not Available
Investigational Site
Warszawa, 02-097
PolandSite Not Available
Investigational Site
London, England SE5 9RS
United KingdomSite Not Available
Investigational Site
Cardiff, Wales CF14 4XW
United KingdomSite Not Available
Investigational Site
Phoenix, Arizona 85013
United StatesSite Not Available
Investigational Site
Beverly Hills, California 90211
United StatesSite Not Available
Investigational Site
Newport Beach, California 92663
United StatesSite Not Available
Investigational Site
Sacramento, California 95819
United StatesSite Not Available
Investigational Site
San Francisco, California 94143
United StatesSite Not Available
Investigational Site
Aurora, Colorado 80012
United StatesSite Not Available
Investigational Site
Bridgeport, Connecticut 06610
United StatesSite Not Available
Investigational Site
Washington, District of Columbia 20010
United StatesSite Not Available
Investigational Site
Washington DC, District of Columbia 20010
United StatesSite Not Available
Investigational Site
Daytona Beach, Florida 32117
United StatesSite Not Available
Investigational Site
Lakeland, Florida 33805
United StatesSite Not Available
Investigational Site
Takoma Park, Maryland 20912
United StatesSite Not Available
Investigational Site
Towson, Maryland 21204
United StatesSite Not Available
Investigational Site
Lincoln, Nebraska 68506
United StatesSite Not Available
Investigational Site
Rochester, New York 14642
United StatesSite Not Available
Investigational Site
Utica, New York 13501
United StatesSite Not Available
Investigational Site
Cleveland, Ohio 44106
United StatesSite Not Available
Investigational Site
Columbus, Ohio 43210
United StatesSite Not Available
Investigational Site
Ephrata, Pennsylvania 17522
United StatesSite Not Available
Investigational Site
Lancaster, Pennsylvania 17602
United StatesSite Not Available
Investigational Site
Sayre, Pennsylvania 18840
United StatesSite Not Available
Investigational Site
Wynnewood, Pennsylvania 19096
United StatesSite Not Available
Investigational Site
Warwick, Rhode Island 02886
United StatesSite Not Available
Investigational Site
Charleston, South Carolina 29425
United StatesSite Not Available
Investigational Site
Germantown, Tennessee 38138
United StatesSite Not Available
Investigational Site
Houston, Texas 77030
United StatesSite Not Available
Investigational Site
San Antonio, Texas 78229
United StatesSite Not Available
Investigational Site
Murray, Utah 84107
United StatesSite Not Available
Investigational Site
Seattle, Washington 98122
United StatesSite Not Available
Investigational Site
Madison, Wisconsin 53713
United StatesSite Not Available
Investigational Site
Wausau, Wisconsin 54401
United StatesSite Not Available

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