Hartaandoening: geleidingsstoornissen Left ventricular dyssynchrony
Conditions
Interventions
Every patient who is enrolled in the study has a PM indication. Patients with
SND receive a standard dual chamber PM and CRT candidates receive a BiV PM.
Pacing leads are placed via standard transve
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Cardiac pacing indication for sinus node dysfunction (2-chamber pacemaker) or indication for a CRT-pacemaker as determined by the treating cardiologist • Greater than 18 years of age • Willing and capable of giving informed consent
Exclusion criteria
Exclusion criteria: • Ventricular pacing dependent • High degree AV block • Previous septal myocardial infarction • Previously implanted pacing device • Abnormal venous anatomy • LV septum wall thickness >10 mm determined by echocardiography • Presence of severe valvular disease • Presence of an ongoing progressive terminal disease associated with a reduced likelihood of survival for the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Successful LV septum lead placement. Placement is considered successful if the lead can be placed in the endocardial LV septum and adequate and stable sensing and pacing tresholds are achieved. Implantation is considered unsuccesfull if the lead cannot be placed due to inability to penetrate the interventricular septum due to anatomic reasons or if a suitable and acutely stable endocardial LV septal site cannot be found due to elevated pacing tresholds, persistent extra-cardiac stimulation or because of hemodynamic instability leading to the termination of the initial implant procedure. • Maintenance of stable lead function using the electrical parameters: sensing value, pacing threshold and lead impedance at baseline versus 6 months follow-up. • Adverse effects of the LV septum lead, with special attention given to the presence of perforation or rupture of the interventricular septum or free wall, pericardial effusion, thrombosis, heart rhythm disturbances, conduction disturbances, lead-/screw dislocation/-fracture. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Acute change in LV systolic function using the hemodynamic parameters LVdP/dtmax and Nexfin LV stroke volume, during LV septum pacing compared to: - RVA pacing and baseline (atrial pacing / AAI mode) in patients with SND. - RVA pacing, single LV epicardial lateral wall pacing, Bi-LV pacing (LV septum and LV lateral wall pacing) and BiV pacing (RV septum and LV lateral wall pacing) and baseline (atrial pacing / AAI mode) in heart failure patients who are candidates for CRT. • Change in sequence of LV electrical activation during LV septum pacing compared to the other above mentioned pacing configurations using the electrocardiographic parameters QRS duration and 3 dimensional QRS vector direction. • Change in regional myocardial deformation patterns during LV septum pacing compared to the other above mentioned pacing configurations using the echocardiographic parameter SPECKLE-tracking strain. • Absolute change in cardiac function using the echocardiographic parameters LVEF (biplane Simpson method), LV End-Systolic Diameter (LVESD), LV End-Diastolic Diameter (LVEDD), LV End-Systolic Volume (LVESV) and LV End-Diastolic Volume (LVEDV) at baseline versus 4-6 weeks follow-up. • Correlation between the non-invasively measured LV stroke volume using Nexfin and the invasively determined LV dP/dtmax. | — |
Countries
Netherlands
Outcome results
None listed