Adults 18 to 80, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Conversion to Sinus Rhythm for at Least 1 Minute Within 90 Minutes From the Start of Study Drug Administration.Primary· 90 minutes from the start of study drug administration
Conversion to sinus rhythm was monitored using a Holter monitoring device through 90 minutes after the start of study drug administration.
If a participant had been monitored for at least 45 minutes and did not convert to sinus rhythm for at least one minute, the primary endpoint was defined as 'no'. If a participant converted to sinus rhythm for at least one minute at any time during the post-treatment 90 minutes observation period, regardless of the length of time monitored, the primary endpoint was to be defined as 'yes'.
Group
Value
95% CI
HSY244
0
Placebo
0
Maximum Observed Plasma Concentration (Cmax)Secondary· Day 1 (0 min (pre-dose), 15 min (end of infusion), 30 min , 60 min, 90 min and 180 min) and Day 5
The Cmax is the maximum (peak) observed plasma drug concentration after single-dose administration.
Actual recorded sampling times were taken into consideration for PK calculations.
Group
Value
95% CI
HSY244
4800
± 3890
Time to Reach the Maximum Concentration After Drug Administration (Tmax)Secondary· Day 1 (0 min (pre-dose), 15 min (end of infusion), 30 min , 60 min, 90 min and 180 min) and Day 5
Tmax is the time to reach maximum (peak) plasma drug concentration after single dose administration (time).
Actual recorded sampling times were taken into consideration for PK calculations.
Group
Value
95% CI
HSY244
0.28
0.25 – 0.30
Area Under the Plasma Concentration-time Curve (AUClast)Secondary· Day 1 (0 min (pre-dose), 15 min (end of infusion), 30 min , 60 min, 90 min and 180 min) and Day 5
AUClast is the AUC from time zero to the last measurable concentration sampling time (tlast).
Actual recorded sampling times were taken into consideration for PK calculations.
Group
Value
95% CI
HSY244
2960
± 1510
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 31 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This was a randomized, placebo-controlled, investigator- and participant-blinded study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of HSY244 in participants with atrial fibrillation (AF), with and without heart failure (HF).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07429214 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
· NA
· recruiting
NCT07271238 — Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
· NA
· recruiting
NCT07388108 — Atrial Dyssynchrony to Predict Arrhythmias in the Postoperative Setting of Cardiovascular Surgery.
· recruiting
NCT07428967 — AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function
· NA
· recruiting
NCT06650995 — AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 20 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04582409.