A Phase 4 interventional study of WACA and PVI and PVAC in Atrial Fibrillation, sponsored by Pier Lambiase. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-06.
Sponsored by Pier Lambiase · Phase 4, Interventional, and Treatment
Atrial fibrillation (AF) is a chaotic heart rhythm of the top chambers of the heart. AF occurs in up to 10% of the population over the age of 60. It is associated with tiredness, impaired functional capacity and is the cause of up to 10% of strokes.
Ablation is a procedure performed with small tubes (catheters) that are introduced through the top of the leg. Burns are made inside of the heart to treat AF. This procedure has been shown to cure 90% of patients with intermittent (paroxysmal) AF.
The investigators currently use either one of two different catheters to create these burns inside the heart. The investigators do not know which is the best catheter to use in patients with paroxysmal atrial fibrillation.
The investigators study will randomly allocate patients to have their ablation performed by either one of the catheters to give a fair comparison between the two. The investigators objective is to study the differences between these two catheters.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 178 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →This is the only study on the registry with Pier Lambiase as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
WACA and PVI
Device: WACA and PVI
PVAC
Device: PVAC
Wide area circumferential ablation (WACA) in the pulmonary vein antrum with subsequent pulmonary vein isolation (PVI) with a single tip irrigated catheter.
Circumferential ablation with a circular ablation catheter (Ablation Frontiers) to electrical silence.
Also known as: Pulmonary vein ablation catheter, Ablation Frontiers
Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording
Time frame: 1 year
Procedural time for pulmonary vein isolation
Time frame: Index procedure
All procedural complications
Time frame: Index
Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure
Time frame: 6 months
Quality of life questionnaire
Time frame: 6 months and 1 year
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.