Advisor HD Grid Observational Study (July 2019 submission)
Research type
Research Study
Full title
Advisor HD Grid Observational Study
IRAS ID
270358
Contact name
Pier Lambiase
Contact email
Sponsor organisation
Abbott Medical UK
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 17 days
Research summary
Heart rhythm problems (arrhythmias) occur when the electrical impulses that coordinate the heartbeats don't work properly, causing the heart to beat too fast, too slow or irregularly. Some heart arrhythmias may cause bothersome or even life-threatening signs and symptoms. Catheter ablation is used to treat many types of arrhythmias, such as Atrial fibrillation (an irregular and often rapid heartbeat that begins in the upper chambers of the heart) and Ventricular tachycardia (a rapid heartbeat that begins in the lower chambers of the heart). The ablation procedure requires the use of a diagnostic mapping catheter, which maps the heart to ensure effective ablation treatment is given by the doctor. The doctor will create a map of the heart to identify the anatomy and the electrical pathways with a mapping catheter in to treat the patient’s heart rhythm disorder as per normal standard practice. The study aims to evaluate whether the use of new market released (CE marked) Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (HD grid) will enable better view of the area of the heart requiring ablation treatment. The purpose of this clinical study is to evaluate the clinical use of HD Grid Mapping Catheter followed by ablation procedures. Further to evaluate the effectiveness of this ablation procedure to treat heart rhythm disorders in real-world clinical settings (via this observational study) using the HD grid mapping catheter to map the heart before the procedure. Patients will be followed up in accordance to standard care at the involved hospitals. Follow ups will occur pre-discharge, 6-months and 12-months. Information will be collected during this study and will include data about the patient’s overall heart condition, the catheter mapping and ablation procedure, and how the patient is following the procedure. Patients will be asked to complete questionnaires about their physical and emotional wellbeing.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
19/LO/1353
Date of REC Opinion
30 Oct 2019
REC opinion
Further Information Favourable Opinion