At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pressure-Volume (PV) Measurements for Evaluating Cardiac Parameters Using BackBeat Medical's Cardiac Neuromodulation Therapy (CNT) Pacing Signals in Different Physiological Pacing Sites: An Acute Study
In Brief
A clinical study evaluating Moderato for Bradycardia and A-V Block. Completed, enrolled 5 participants across 1 site.
Signals
Detailed Summary
In a multicenter non-randomized acute setting, eligible subjects requiring implant or replacement of an IPG (pacemaker, ICD, CRT-P, CRT-D) will be instrumented to study the effect of CNT from different locations in the RV. CNT effects on BP will be evaluated with a PV conductance catheter in the LV, and with optional BP catheters in the aorta and/or RV. CNT will be delivered by externally by the BackBeat Moderato System IPG. Abbreviations: CNT, Cardiac Neuromodulation Therapy; IPG, Implanted Pulse Generator; ICD, Implanted Cardiac Defribillator; CRT-P or D, Cardiac Resynchronisation Therapy-Pacemaker or Defibrillator; RV, Right Ventricle; LV, Left Ventricle; BP, Blood Pressure
Study Details
Timeline
Arms & Interventions
Eligible subjects instrumented for CNT testing
Interventions
Several algorithms comprising CNT will be delivered by the Moderato Implantable Pulse Generator. Each application will last approximately 3 min with 2 minutes baseline (regular pacing) between them. Hence, each subject will serve as its own control (during pacing) and test (during CNT application). Furthermore, the average control value for the whole group will be compared with the average test values of CNT algorithms at the different ventricular lead locations for efficacy assessments. Stratification of subjects by initial hemodynamic parameters (such as Ejection Fraction, for example) would be possible depending on the total number of subjects in each group.