Recommendation ID

Further research in people who could have conventional cardiac pacemaker implantation should report the patient selection criteria and compare leadless pacemakers with conventional pacemakers. Follow-up should be for at least 5 years and outcomes should include adverse events, symptom relief, quality of life and device durability in the long-term.

Any explanatory notes
(if applicable)

Evidence on the safety of leadless cardiac pacemaker implantation for bradyarrhythmias shows that there are serious but well-recognised complications. The evidence on efficacy is inadequate in quantity and quality:
- For people who can have conventional cardiac pacemaker implantation, leadless pacemakers should only be used in the context of research.
- For people in whom a conventional cardiac pacemaker implantation is contraindicated following a careful risk assessment by a multidisciplinary team, leadless cardiac
pacemakers should only be used with special arrangements for clinical governance, consent and audit or research.

Source guidance details

Comes from guidance
Leadless cardiac pacemaker implantation for bradyarrhythmias
Date issued
August 2018

Other details

Is this a recommendation for the use of a technology only in the context of research? No  
Is it a recommendation that suggests collection of data or the establishment of a register?   Yes  
Last Reviewed 31/08/2018