Role of Poly Unsaturated Fatty Acids (PUFAs) in the management of Paroxysmal Atrial Fibrillation (PAF) - PUFA-PAF STUDY
- Conditions
- Paroxysmal Atrial FibrillationMedDRA version: 9.1 Level: LLT Classification code 10034039 Term: Paroxysmal atrial fibrillation
- Registration Number
- EUCTR2006-006863-22-GB
- Lead Sponsor
- niversity Hospital of South Manchester NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method