WAVE-MAP AF
Research type
Research Study
Full title
High-Density Wave Mapping in Subjects with Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
IRAS ID
265195
Contact name
Joanne O'Beirne-Elliman
Contact email
Sponsor organisation
Abbott Medical Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 3 days
Research summary
Heart rhythm problems (arrhythmias) occur when the electrical impulses that coordinate the heart to beat, don't work properly, causing the heart to beat too fast, too slow or irregularly. For those heart rhythm problems that are troublesome to health, a procedure called catheter ablation is used as treatment. To help treat heart rhythm problems, maps of the heart are created by the doctor (Electrophysiologist) to help visualize the area(s) of the heart that are not working properly and may require treatment. These maps are called WAVE-maps and are created by a medical device called the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (HD Grid).
This study is intended to support marketing claims for the HD Grid as the Wave maps collected will be analysed to help further understand how this additional mapping could improve patient outcomes.
Participants of the study will receive the catheter ablation treatment as per standard of care. The procedure may take up to an extra 50 minutes if the patient takes part in the study because in this time the doctor will take additional maps of the heart, known as WAVE-mapping. All standard of care procedural data, along with these maps will be used as part of this research. Participants will be asked to take part in the study for up to 13-months. Participants will then be followed up at 3-, 6-, and 12-months after the procedure. At each follow up appointment, participants will be asked about any hospital visits they have had since their last appointment, their medication will be reviewed. At the 3- and 12-month follow ups their heart rhythm will also be checked.
At each participating NHS hospital, up to 60 patients with a heart rhythm problem called atrial fibrillation will be invited to take part in the study.
REC name
London - Stanmore Research Ethics Committee
REC reference
19/LO/1450
Date of REC Opinion
13 Dec 2019
REC opinion
Further Information Favourable Opinion