A study to determine the effectiveness of a new medicine (XEN-D0103) in patients who have an irregular and often fast heart beat (which comes and goes) and who are fitted with a pacemaker.

• Conditions: Paroxysmal atrial fibrillation; MedDRA version: 16.1Level: LLTClassification code 10034039Term: Paroxysmal atrial fibrillationSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-004456-38-GB
• Lead Sponsor: Xention Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-26
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Written informed consent.
2. Patients of either sex, aged 18 years and older with paroxysmal AF confirmed within 6 months prior to Screening and Washout.
3. Dual chamber pacemaker with appropriate arrhythmia diagnostics for at least 1 month prior to Screening and Washout
4. Able to tolerate withdrawal of Class I and III antiarrhythmic drugs (such as Flecainide, Sotalol, Dronedarone or Amiodarone).
5. Able to tolerate pacemaker antiarrhythmic algorithms being turned off at Screening and Washout, if applicable.
6. Evidence of AF burden 1% and 50% prior to Visit 2 (Day 1).
7. Anticoagulated in accordance with European Society of Cardiology (ESC) Guidelines.
8. Women must be of non child bearing potential. Non-child bearing potential is defined as amenorrheic for at least 2 years AND have serum follicle stimulating hormone [FSH] level of at least 30 IU/L) or have undergone a hysterectomy or bilateral oophorectomy (tubal ligation is not acceptable). If partners of male patients are of childbearing potential, the patient must be willing to use contraception (e.g. condoms).In addition, their female partner must also be using contraception (e.g. hormonal, intra-uterine device etc). This double contraception must be used from the first dose of study drug until at least 90 days after the last dose of study drug
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Cardiac ablation procedure within 3 months prior to Screening and Washout.
2. QTc interval >450 ms on Day 1.
3. History of clinically significant ventricular arrhythmia.
4. History of long QT syndrome.
5. Concomitant treatment with any Class I or III anti-arrhythmic drugs (such as Flecainide, Sotalol, Dronedarone or Amiodarone) on Day 1. Treatment with oral Amiodarone must be stopped 6 weeks prior to Study Day 1. In the case of intravenous Amiodarone, a cumulative dose of >5g in the period between Screening and Washout and Day 1 is unacceptable. In the case of all other Class I or III anti-arrhythmic drugs, they must be stopped for at least 2 weeks prior to Day 1.
6. Heart failure with symptoms consistent with New York Heart Association [NYHA] classes III-IV. Patients with NYHA I-II heart failure can be enrolled if there have beenno hospital admissions for exacerbations of heart failure within 6 months prior to screening
7. Myocardial infarction within 3 months of Screening and Washout; coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]) within 6 months of Screening and Washout, or unstable angina within 3 months of the Screening and Washout.
8. Transient ischaemic attack (TIA) or stroke within 3 months of Screening and Washout.
9. Body mass index (BMI) >36 kg/m2 at Screening and Washout.
10. Patient is unable or unwilling to co-operate with the study procedures.
11. Participation in any other clinical trials within 30 days prior to Screening and Washout.
12. Substance or alcohol abuse (as defined by Diagnostic and Statistical Manual of Mental Disorders Forth Edition) within 6 months of Screening and Washout.
13. The following laboratory abnormalities at Screening and Washout, with the provision that repeat samples may be considered for this criterion at the discretion of the Sponsor:
a. Serum potassium of <3.5mmol/L or >5.5mmol/L
b. Serum magnesium <0.7mmol/L
c. Calculated creatinine clearance (using the Cockcroft-Gault method) of <50ml/min
d. Serum alanine transaminase (ALT), aspartate transaminase (AST) or gamma-glutamyl transpeptidase (GGT) greater than twice the upper limit of normal (ULN).
e. Total serum bilirubin >1.5x ULN.
f. Serum haemaglobin <9g/L (women) or 11g/L (men)
14. Taking medication which is a CYP3A4 substrate with a narrow therapeutic window (see section 9.8.3)
15. Evidence of any other clinically significant disease or condition which in the opinion of the Investigator would preclude the patient's participation in this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified