Heart failure & cardiomyopathies
Leadless Ultrasound-Based Cardiac Resynchronization System in Heart Failure
Authors' conclusion
The SOLVE-CRT study has demonstrated that leadless LV endocardial pacing with the WiSE CRT system is associated with a reduction in LVESV in patients with HF.
Study context
- Population
- Heart failure (HF) patients who were cardiac resynchronization therapy (CRT) nonresponders, previously untreatable (PU) or high-risk upgrades (HRU)efficacy analysis n = 100
- Participants
- 183 patients
- Outcome
- Efficacy: reduction in mean LVESV; safety: freedom from type I complications
- Follow-up
- 6 months
Methodological detailsrandomised double-blind part and single-arm part combined, 36 centres in Australia, Europe and the US, randomised double-blind part (n = 108), single-arm part (n = 75), terminated at interim analysis for meeting prespecified stopping criteria, Enrolment January 2018 through July 2022
- Randomised double-blind part and single-arm part combined
- 36 centres in Australia, Europe and the US
- Randomised double-blind part (n = 108)
- Single-arm part (n = 75)
- Terminated at interim analysis for meeting prespecified stopping criteria
- Enrolment January 2018 through July 2022
Main finding
As reported in the abstract
Reduction in mean LV end systolic volume (LVESV) (primary efficacy end point met)
16.4%
95% CI −21.0% to −11.7%P = .003
Observational data: associations, not effects.
Safety
Freedom from type I complications (primary safety end point) · 6 months
- Freedom from type I complications
- 80.9%
- Primary safety end point met
- P < 0.001
- Study device system events
- 12 (6.6%)
- Vascular events
- 5 (2.7%)
- Strokes
- 3 (1.6%)
- Cardiac perforations (mostly early in the study)
- 7 (3.8%)
- Safety population: all participants
Original publication
Leadless Ultrasound-Based Cardiac Resynchronization System in Heart Failure. JAMA Cardiol. Published 1 October 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →