VENTURE-AF

• Research type

  Research Study

• Full title

  A Randomised, Open-label, Active-controlled, Multi-centre Study to Evaluate the Safety of Rivaroxaban and Vitamin K Antagonists in Subjects Undergoing Catheter Ablation for Atrial Fibrillation

• IRAS ID

  117185

• Contact name

  David Wyn Davies

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2012-001484-79

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Patients with an irregular heartbeat (fibrillation) can be treated by identifying the region of the heart muscle that has developed the problem and then altering the muscle cells in that region so that they no longer play a part in the pumping of the heart. The remaining cells then give the desired normal pumping pattern. The treatment is to alter the cells in the area that is causing the problem, called ablation. Small electrodes (catheters) are introduced into the heart through an insertion into the femoral artery (the main blood supply into the leg). One of the risks of such an irregular heartbeat in the upper chambers (atria) of the heart is that blood can ??pool?? in that area and clots can form. These clots can pass throughout the bloodstream and cause problems such as stroke or embolism, where they can lead to permanent secondary problems. The ablation procedure itself has a risk of clots due to the invasive nature of the technique. Blood-thinning drugs are used to reduce the bloods clotting threshold, both in the management of atrial fibrillation and also before, during and after catheter ablation. Lowering the clotting ability of the blood itself brings with it risks, such as an internal bleed, such as a stroke (clot lodged in the brain, causing death of that part of the brain) or pulmonary embolism (clot lodged in the lung, causing death of that part of the lung). This study will look at a newer blood-thinning drug, Rivaroxaban, compared to older drugs (vitamin K antagonists, VKA, of which warfarin is an example) in patients treated for atrial fibrillation by catheter ablation. Rivaroxaban has a licence for use on prescription for its ability to safely reduce the risk of such internal bleeds in other circumstances where clots are a problem, such as hip and knee replacement surgery. The clinical trial is to see if fewer Rivaroxaban-treated subjects suffer consequences of a clot entering the blood stream (pulmonary embolism, other internal bleeds which lead to death (called a ??vascular death??), than do those that receive the usual current treatment, VKA.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  12/LO/1861

• Date of REC Opinion

  30 Jan 2013

• REC opinion

  Further Information Favourable Opinion