What is a clinical study?

This is research that involves human volunteers. They are set up to try and add to medical knowledge- usually by answering a question that may lead to an improvement in patient care.

There are two categories of clinical studies- interventional or observational. The terms are used to describe what is being asked of the participants. Interventional studies involve an ‘intervention’ being done for research purposes and the investigators can then assess the impact of this. Although the word ‘intervention’ may spark thoughts of new surgeries or procedures, it also refers to new drug or changes in care or lifestyle (such as physiotherapy programmes, changes in diet or going to smoking cessation classes)- things that are done to the participant that are not a currently part of routine care.

Observational studies are ones in which investigators monitor how participants respond to standard care. The researchers may select the types of participants they want to monitor and under what scenario such as the long-term health of elderly patients having a specific type of routine heart surgery. So patients can have interventions in observational studies but the difference is these interventions are already a part of routine care.

In the AFHF study, although patients will have a medical intervention (an AF catheter ablation procedure) this is a part of their routine clinical care. So if that was it, it would be an observational study. Because we are asking the participants to have other non-invasive tests like an MRI scan, it  is classed as an interventional study- these tests aren’t routine for patients in this scenario (although MRIs are very common for patients with other symptoms and heart issues).

The AFHF study, the CSAF-AW study and the AFFU-AW study were all conceived and designed by the medical doctors on the research team. Therefore these studies are also categorised as ‘investigator-conceived, investigator-led’ research studies.