Arrhythmias & electrophysiology
A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery (LENIENT)
Study context
- Population
- Patients receiving a de novo cardiac implantable electronic device (CIED) or upgrades and revisions requiring a new lead implantplanned 1,250 per group
- Planned comparison
- Lenient vs strict (restrictive) postoperative arm and activity instructions after CIED surgery
- Primary endpoint
- Composite of:
- Lead dislodgement
- Frozen shoulder
- Upper extremity venous thrombosis
- Clinically significant hematoma
- Infection
- Follow-up
- Within 52 weeks of index surgery
Methodological detailsstudy protocol, single-centre, nonblinded, noninferiority, 6 randomly assigned 8-month periods, Individual consent waived, Instructions given at discharge, reinforced by recurrent interactive voice recognition (IVR) phone calls, text messages and emails
- Study protocol
- Single-centre
- Nonblinded
- Noninferiority
- 6 randomly assigned 8-month periods
- Individual consent waived
- Instructions given at discharge, reinforced by recurrent IVR phone calls, text messages and emails
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery (LENIENT). Am Heart J. Published 25 January 2023. doi:10.
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