LAA-Occluder Trial OCC2012-02, Version 6, 27NOV2016
Research type
Research Study
Full title
Prospective, non-randomized, safety and efficacy study of a new occluder design for minimally invasive closure of the left atrial appendage (LAA) in patients with atrial fibrillation (AF).
IRAS ID
200173
Contact name
Iqbal Malik
Contact email
Sponsor organisation
Occlutech International AB
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CIV-13-09-011614, EudaMed ID; 94.1.10 - 5660 – 8657, BfArM ID (CA in Germany)
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Years of clinical research have shown that atrial fibrillation (heart rhythm disorder) significantly increases the risk of a stroke and stroke-related death. Atrial fibrillation (AF) is a heart rhythm disorder that causes a very irregular heartbeat. This can cause blood to form clots in an area inside the heart called the left atrial appendage (LAA).
If these clots become dislodged they may clog up fine blood vessels either causing a stroke or vascular occlusions in e.g. the eyes, limbs etc. One method to prevent clots formed inside the LAA being released, is to close or “occlude” it.Occlutech has developed a medical device, the Occlutech® LAA Occluder (LAAO) that is inserted into the LAA of your heart using a catheter technique and is lodged in the left heart chamber. The Occlutech® LAA Occluder is a permanent implant. The Occlutech® LAA Occluder is made of materials that are commonly used in medical devices. Animal studies conducted by Occlutech have shown that Occlutech® LAA Occluders are safe and effective in their ability to permanently close the LAA.
This clinical study aims to evaluate the safety and efficacy of the Occlutech® LAA Occluder for catheter based closure of the left atrial appendage.
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/0796
Date of REC Opinion
14 Jun 2016
REC opinion
Further Information Favourable Opinion