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Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation: A Safety and Feasibility Study

NCT02028130 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-06-03

No results posted yet for this study

Summary

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.

Conditions

  • Persistent Atrial Fibrillation

Interventions

PROCEDURE

LAA electrical isolation + occlusion

LAA electrical isolation + Watchman device implantation to occlude LAA

Sponsors & Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Tom Wong, MD · Royal Brompton & Harefield NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02028130 on ClinicalTrials.gov