Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation: A Safety and Feasibility Study (LEIO-AF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02028130|
Recruitment Status : Unknown
Verified June 2014 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was: Enrolling by invitation
First Posted : January 6, 2014
Last Update Posted : June 3, 2014
Atrial fibrillation (AF) affects as many as 1 in 16 people over the age of 65 and reduces the quality of life of large numbers of people in the UK and around the world. Catheter ablation is a minimally invasive treatment that has been developed to help eliminate AF. Recent studies have identified that a particular area of the heart, namely the left atrial appendage (LAA), which is a pouch in the left atrium (small collecting chamber of the heart), may be the main source of AF in many cases. There is a clear lack of knowledge about the structure, anatomy, function and electrical properties of the LAA, which is fundamental to furthering our understanding and management of AF.
In addition, it is well known that AF significantly increases the risk of stroke. The majority of strokes occur due to blood clots forming in the LAA. Traditionally, the most effective treatment to minimise the risk of stroke has been to thin the blood with agents such as warfarin. This therapy requires regular blood tests at much inconvenience to patients and increases the risk of bleeding complications. Recently, a large study demonstrated that use of an implanted device (Watchman®) to occlude the LAA is as effective as warfarin in preventing stroke and confers a lower mortality rate.
We aim to investigate whether it is safe and feasible to ablate the LAA and to implant a Watchman® device during the same procedure in patients who are in atrial fibrillation all of the time.
|Condition or disease||Intervention/treatment|
|Persistent Atrial Fibrillation||Procedure: LAA electrical isolation + occlusion|
While catheter ablation has revolutionized the treatment of atrial fibrillation (AF), the long-term outcomes in treating persistent AF are variable, often requiring more than one procedure to maintain long-term freedom from AF. Electrical isolation of the pulmonary veins (PVs) is central to catheter ablation strategies, with the majority of paroxysmal AF recurrences being associated with reconnection of previously isolated PVs. Persistent AF is different, with recurrences being attributable to foci and or substrate outside the PVs, including the left atrial appendage (LAA). Recently, a non-randomised, consecutive study of 987 patients undergoing repeat catheter ablation for persistent (82%) and paroxysmal (18%) AF has demonstrated that almost 30% of recurrences were due to an LAA focus and that the addition of LAA electrical isolation to a standard persistent AF ablation strategy improves freedom from AF.
Percutaneous LAA occlusion has been demonstrated to be as effective as warfarin in reducing the risk of thromboembolic stroke in patients with AF. The combination of a standard AF ablation lesion set with LAA electrical isolation and LAA occlusion may be an elegant method of improving success rates of ablation for persistent AF whilst also mitigating stroke risk and reducing the bleeding risks from long-term anticoagulation. However, the feasibility and safety of concomitant endocardial electrical isolation and mechanical occlusion of the LAA is not known.
In this study we test the hypothesis that concomitant electrical isolation of the LAA and its occlusion with a Watchman device, following a standard persistent AF lesion set is feasible and safe.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Safety and Feasibility of Concomitant Left Atrial Appendage Electrical Isolation and Occlusion in the Treatment of Persistent Atrial Fibrillation|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||October 2014|
Experimental: LAA electrical isolation + occlusion
Standard persistent AF ablation protocol + LAA electrical isolation + Watchman device implantation to occlude LAA
Procedure: LAA electrical isolation + occlusion
LAA electrical isolation + Watchman device implantation to occlude LAA
- Feasibility of concomitant LAA electrical isolation and percutaneous left atrial appendage occlusion using Watchman® device in patients with persistent atrial fibrillation [ Time Frame: At time of procedure ]Success rates of LAA electrical isolation and Watchman® device implantation post-LAA isolation will be determined during index procedures
- Freedom from serious adverse events (stroke, myocardial infarction, emergency surgery, death) immediately after the procedure and during follow-up [ Time Frame: Immediately after the procedure and at 6 months ]Serious adverse event rate will be determined immediately after the procedure and during the 6 month follow-up period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028130
|Royal Brompton & Harefield NHS Foundation Trust|
|London, Greater London, United Kingdom, SW3 6NP|
|Principal Investigator:||Tom Wong, MD||Royal Brompton & Harefield NHS Foundation Trust|