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

NARecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

November 22, 2024

Primary Completion Date

March 1, 2026

Study Completion Date

April 1, 2026

Conditions
Heart Failure With Reduced Ejection Fraction
Interventions
DEVICE

Atrial pacing with respiratory sinus arrhythmia (RSA) variability

The intervention in this study is a modification of the pacing output from a standard external pacemaker such that it will approximate the RSA variation found in healthy subjects. A pacemaker (PACE204, Osypka Medical AG), similar to those currently in common use in post-CABG patients, will be adapted to receive an additional input signal based on the respiratory signal (Ceryx device). The respiration signal will be combined with the ECG signal to determine the appropriate pacing interval. The pacing impulse will be delivered by the pacemaker unit.

DEVICE

Monotonic right atrial overdrive pacing

Pacing is delivered by a PACE204 pacemaker (Osypka Medical AG) delivering standard monotonic right atrial pacing

Trial Locations (1)

CF14 4XW

RECRUITING

Cardiff & Vale University Health Board, Cardiff

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Cardiff and Vale University Health Board

OTHER_GOV

lead

Ceryx Medical Ltd

INDUSTRY