Paroxysmal Atrial Fibrillation MedDRA version: 9.1 Level: LLT Classification code 10034039 Term: Paroxysmal atrial fibrillation
Conditions
Interventions
Product Name: Cardiozen
Pharmaceutical Form: Capsule*
Concentration unit: mg milligram(s)
Concentration type: not less then
Concentratio
Sponsors
University Hospital of South Manchester NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients who have PAF and a dual chamber pacemaker, who have shown an AF burden of =10% in the most recent pacing check and are not symptomatic from it. New Criteria as per '2006/CD/013-VERSION-2-10/05/2007' substantial amendment. The inclusion criteria specifies a very high rate of paroxysmal atrial fibrillation which is not necessary to show a difference. As the difference to be perceived is a percentage of the burdena realistic AF burden ( reflecting the clinical occurrence of Af in these patients) would enable us to recruit more patients with out influencing the significance of the difference that would be seen betwenn the active and the placebo group. Hence we wish to change the inclusion criteria relating to the Af burden to > or =3% Af burden to > or = 3% 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with persistent atrial fibrillation. Patients who are already on class-1 or class-3 anti-arrhythmic therapy. Patients who have been taking omega-3 supplements or have done so within a three month period preceding enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of oral supplementation of PUFAs on the frequency and duration of AF episodes in patients known to have paroxysmal atrial fibrillation with a high (=10%) AF burden and who already have a pacemaker in situ.;Secondary Objective: To evaluate the role of fish oils on inflammatory markers and co-relate the relationship to AF burden.;Primary end point(s): Number of mode switch episodes during pacemaker check (a surrogate for AF) as a measure of AF burden. | — |
Countries
United Kingdom
Outcome results
None listed