The study will test the hypothesis that ablation of paroxysmal atrial fibrillation in hypertensive subjects is more effective when a ROX coupler is inserted concurrently.
The single blinded, randomised study is planned to commence in October 2014 after obtaining Research Ethics Committee and NHS Research and Development approval. A target of 20 participants with symptomatic paroxysmal AF will be recruited. All participants will be blinded and randomised to AF ablation only or AF ablation + ROX coupler implant. All participants will have right and left heart catheterisation prior to AF ablation +/- ROX coupler insertion. Participants will be followed up 6 weeks, 3, 6 months and 12 months after the ablation. The study will take place at Eastbourne District General. The study duration per patient is 13months. The overall study duration will be 18 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Percutaneous catheter ablation for Atrial fibrillation.
The ROX Coupler is a CE-marked device designed to maintain an iliac arteriovenous fistula
Eastbourne District General Hospital
Eastbourne, East Sussex, United Kingdom
AF ablation success
No AF burden detected on implantable loop recorder
Time frame: 3 months
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