None listed
Conditions
Brief summary
The purpose of this study is to assess the utilisation of an Implantable Loop Recorder to aid in the management of symptom control of Paroxysmal Atrial Fibrillation.We hypothesise that an Implantable Loop Recorder can be effectively used in a nurse led cardiologist supported AF clinic to guide and co-ordinate the management of patients with a high burden of symptoms related to their Atrial Fibrillation.
Interventions
Implantable Loop Recorders utilised in the interventional group to help with the management of a patient's Paroxysmal Atrial Fibrillation.
The insertion of the Implantable Loop Recorder is inserted with the incision tool and insertion kit provided by Medtronic under aseptic technique. The Loop Recorder is inserted in one of 2 thoracic anatomic locations. These are over the fourth intercostal space on the left hemi thorax: 45° (“best”) or parallel (“good”) relative to the sternal border. During i
Implantable Loop Recorders utilised in the interventional group to help with the management of a patient's Paroxysmal Atrial Fibrillation. The insertion of the Implantable Loop Recorder is inserted with the incision tool and insertion kit provided by Medtronic under aseptic technique. The Loop Recorder is inserted in one of 2 thoracic anatomic locations. These are over the fourth intercostal space on the left hemi thorax: 45° (“best”) or parallel (“good”) relative to the sternal border. During implantation, data on R waves will be collected from the value reported on-screen by the programmer. It will be inserted by an Electrophysiologist Cardiologist and takes around 30 minutes to insert. Post implantation, the patient will receive the home monitoring device with instructions about its use for nightly automated transmissions which will give the Atrial Fibrillation Nurse alerts to any arrhythmias/atrial fibrillation episodes. The Implantable Loop Recorder will be removed at the end of its battery life which is around three years. The overall duration of the intervention will be 36 months (3 years) until the end of the Implantable Loop Recorder's battery life.
Sponsors
Melissa Harvey
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Over the age of 18 years and under the age of 75 years. - Documented evidence of Paroxysmal Atrial Fibrillation through any type of ECG or Holter monitoring. - A high burden of Atrial Fibrillation symptoms reported by the patient (at least monthly). - A normal heart structure and normal left ventricular function. Normal LVEF. Normal valves. - Subject able and willing to give informed consent and return for all required study follow-up visits
Exclusion criteria
- Under the age of 18 years and over the age of 75 years. - Documented Persistent AF. - Documented Atrial Flutter. - Documented reversible cause for AF e.g. thyroid disease. - Previous cardiac surgery. - Structural heart disease. - Previous left atrial ablation. - Subject has an active systemic infection. - A history of unstable angina, previous myocardial infarction or percutaneous intervention. - A history of chronic obstructive pulmonary disease or evidence of other significant lung disease. - Contraindication for oral anticoagulation. - Previous TIA or stroke. - Significant congenital heart defect. - Evidence of congestive cardiac failure or left ventricular dysfunction. - Hypertrophic cardiomyopathy. - Abnormal long or short QT interval, signs of Brugada syndrome or Arrhythmogenic right ventricular dysplasia. - History of sarcoidosis. - History of myxoma. - Pregnancy or breastfeeding. - Life expectancy less than 2 years. - Subject is employed by Medtronic or a close relative of investigators.
Outcome results
None listed