Active Heart, Stroke & Blood NIHR-supported project Digestion, Kidneys & Other Organs

An observational post-marketing study for evaluation of ongoing safety and effectiveness of catheter mapping and ablation using commercially approved BWI medical devices for the treatment of patients with cardiac arrhythmias

Funder NIHR (part of DHSC)
Recipient organisation NIHR Guy's and St Thomas' Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Feb 2025 — Dec 2027

In plain English

AI plain-English summary

Every year, thousands of UK patients undergo catheter ablation for heart rhythm disorders using devices already on the market, but no one is systematically tracking how well these tools perform in routine hospital care. Clinical trials typically test medical devices under ideal conditions with strict protocols. This study does something different: it follows real patients in real hospitals, collecting data from standard procedures without adding extra tests or visits. The gap is that safety and effectiveness data from controlled trials may not reflect what happens when devices are used by different doctors in different hospitals on a wider range of patients. If this research succeeds, it will confirm that commercially approved ablation devices work safely in everyday NHS practice. The data could also reveal which techniques or patient groups benefit most, helping clinicians refine their approach. For patients, this means more reliable treatment for irregular heartbeats without unnecessary risk. For the health system, it provides evidence that supports continued use of these devices and may inform future procurement decisions. This is not fundamental science—it is a practical, post-market surveillance study that fills a gap between regulatory approval and real-world use.

View original technical description
This is a prospective, multi-center, non-randomized, observational, post-marketing study.Prospective: The study follows over time a group of individuals who have a similar medical condition.Multi-center: Several hospitals will be involved in this study. Non-Randomized: The treatment will not be chosen at random, it will not be decided by chance.Observational: No visit or assessment will be conducted specifically for the study. We will be looking at the information that would be collected according to the standard of care, even if the subject would not be participating in the study.Post-marketing: All medical devices used in this study are already commercially available.Study participants will have the ablation procedure according to the standard of care of their hospital and according to their physician’s preference. There is no specific assessment or intervention required specifically for the study.This study gives a general structure to collect data of study participants that are treated for their irregular heart rhythm according to the hospital standard of care using medical devices of Biosense Webster that are available on the market.The data collected with this study will be used to confirm the safety and performance of the medical devices of Biosense Webster that are available on the market.Additionally, the data collected will broaden the evidence on the use of these devices and techniques to treat irregular heart rhythm.

Researchers

Tom Wong (Principal Investigator)

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