Heart failure & cardiomyopathiesRandomised controlled trial
Rationale and design of a randomized, sham-controlled, clinical trial for evaluation of the Edwards APTURE transcatheter shunt system (ALT-FLOW II)
- Design paper of a randomised controlled trial
- prospective
- multicentre
- sham-controlled
- double-blind (patient and assessor)
- 1:1 randomisation
Authors' conclusion
The ALT-FLOW II trial will evaluate the safety and performance of the APTURE system in symptomatic HFpEF and HFmrEF patients with elevated left atrial pressure.
Study context
- Population
- Symptomatic heart failure (HF) patients ≥18 years with LVEF >40%, exercise pulmonary capillary wedge pressure (PCWP) ≥25 mm Hg and PCWP to right atrial pressure gradient ≥8 mm Hg; excluding severe HF, significant valvular disease, more than mild RV dysfunctionplanned (approximately)
- Participants
- 100 patients
- Comparison
- APTURE shunt vs sham control
- Primary endpoint
- Safety of the APTURE device; change in workload-corrected PCWP normalized to bodyweight
- Follow-up
- 30 days (safety); 6 months (PCWP)
Original publication
Rationale and design of a randomized, sham-controlled, clinical trial for evaluation of the Edwards APTURE transcatheter shunt system (ALT-FLOW II). Eur J Heart Fail. Published 8 January 2026. doi:10.1093/ejhf/xuaf016
Summarised from the published abstract; every number is checked against it