Milestone Launches Phase 4 PSVT Registry to Enroll 450 Patients Across 20 Sites
Milestone Pharmaceuticals will enroll 450 adult PSVT patients at 20 sites in its Phase 4 RESET-PSVT registry by end-2026 to collect real-world evidence on CARDAMYST nasal spray use. The study’s primary endpoints chart dosing patterns and episode frequency while secondary analyses evaluate patient quality of life and healthcare utilization.
1. Registry Design and Timeline
Milestone will partner with Duke Clinical Research Institute to conduct RESET-PSVT, a Phase 4, multicenter, prospective observational registry enrolling approximately 450 adults with PSVT across 20 electrophysiology and cardiology sites. Enrollment is slated to begin by late 2026.
2. Study Endpoints and Analyses
The primary endpoint will chart CARDAMYST dosing patterns, episode frequency, doses per episode and usage triggers. Secondary endpoints compare CARDAMYST and non-CARDAMYST users on patient-reported quality of life and healthcare utilization, with exploratory subgroup analyses planned.
3. Implications for Real-World Evidence
This registry aims to expand evidence beyond controlled trials, offering insights into acute PSVT management with CARDAMYST nasal spray in routine practice. Real-world data on episode burden and patient experience may support broader clinical adoption and inform future guidelines.