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NCT06359938 · ClinicalTrials.gov record · last posted 2026-08-05

Respiratory Sinus Arrhythmia (RSA) Pacing Post-CABG Surgery in Patients With HFrEF

Study acronym: RSA-PACE
StatusCompleted
PhaseNot applicable
Started2024-11-22
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from the ClinicalTrials.gov record
The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out. The main questions the trial aims to answer are: * Is the new type of pacemaker safe? * Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)? Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients.

Protocol amendment history 4 changes detected by DataLookout

2026-08-06
notable
Trial completed
2026-08-06
critical
Enrollment reduced: 54 → 30 participants
2026-08-06
notable
Primary completion pushed: 2026-03-01 → 2026-07-31
2026-08-06
minor
Completion pushed: 2026-04-01 → 2026-07-31
Trial Details
NCT Number NCT06359938
Lead Sponsor Ceryx Medical Ltd
Collaborators: Cardiff and Vale University Health Board
Conditions Heart Failure With Reduced Ejection Fraction
Enrollment 30 participants
Start Date 2024-11-22
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-05