Guidance

1 Recommendations

1 Recommendations

1.2

This procedure should only be done as part of a formal research study, with NHS research ethics committee approval.

More research

1.3

More research, in the form of suitably powered randomised controlled trials and supported by safety data from a registry, is needed on:

  • patient selection

  • type of procedure

  • changes in cardiac function

  • quality of life

  • short- and long-term outcomes

  • safety outcomes.

Why the committee made these recommendations

There is very limited short- and long-term evidence on the efficacy and safety of this procedure. Also, the evidence comes from studies that used different techniques to do the procedure, and varied in the number and type of implants used. It is also unclear who would benefit from this procedure. So, it should only be used in research.