Advisor HD Grid Observational Study
Research type
Research Study
Full title
Advisor HD Grid Observational Study
IRAS ID
257826
Contact name
Pier Lambiase
Contact email
Sponsor organisation
Abbott Medical UK
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 15 days
Research summary
Heart rhythm problems (heart arrhythmias) occur when the electrical impulses that coordinate your heartbeats don't work properly, causing your heart to beat too fast, too slow or irregularly. Heart arrhythmias may feel like a fluttering or racing heart and may be harmless. However, some heart arrhythmias may cause bothersome — sometimes 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 during the procedure. The doctor will create heart maps and treat the patient’s heart rhythm disorder as per normal standard practice in hospital. The study aims to evaluate whether the use of 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 the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (HD grid) during ablation procedures, and the effectiveness of this ablation procedure to treat heart rhythm disorders in real-world clinical settings (via this observational study). Patients will be followed up in addition to their normal standard care. 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 which include how they are physically and emotionally feeling.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/0979
Date of REC Opinion
28 Jun 2019
REC opinion
Unfavourable Opinion