Medtronic Cardiac Ablation Registry platform
Research type
Research Study
Full title
Medtronic Cardiac Ablation (MCA) Registry, base CIP
IRAS ID
294290
Contact name
Tarvinder Dhanjal
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 8 months, 31 days
Research summary
The Medtronic Cardiac Ablation Registry platform will look at the performance (i.e. how well) and safety of different Medtronic Ablation Systems.
Cardiac Ablation therapy is used to treat irregular heart rhythms. Cardiac ablation therapy is established as an acceptable therapy to treat patients with AF when drug therapy has failed. Current ablation systems ablate heart tissue by either heating or freezing the tissue.
The registry is not an experimental study. For this registry, we will only be collecting data, assessed in a "real-life" environment, where patients are managed as they would be in routine care, using devices already approved. The duration of data collection will be determined by the product received by the patient. The registry design allows for new, already approved Medtronic Ablation products, to be added over time.The DiamondTemp Addendum:
The first approved product added to the Medtronic Cardiac Ablation Registry is called DiamondTemp. The aim of this study is to look at the number of safety events and how well controlled patients heart rhythms are in the 12months following treatment with the study device.REC name
North East - York Research Ethics Committee
REC reference
21/NE/0092
Date of REC Opinion
6 Aug 2021
REC opinion
Further Information Favourable Opinion