Atrioventricular block, chronic heart failure Atrioventricular block, chronic heart failure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients indicated for newly permanent pacemaker implantation due to advanced atrioventricular block (second and third degree). Patients with complicated heart failure and moderately decreased left ventricular ejection function (35-50%) before implantation. High frequency of ventricular pacing with >40% after implantation.
Exclusion criteria
Exclusion criteria: Patients indicated for defibrillator lead implantation Patients who are not required for permanent pacemaker implantation owing to temporal atrioventricular block Anatomical difficulty of transvenous lead implantation Upgrading cases from prior pacemaker devices or re-implantation cases Inability to obtain informed consent from a patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An improvement of LVEF from before to after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| An improvement of BNP levels from before to after 6 months An improvement of LVEDV, LVESV, LVDd, and LVDs from before to after 6 months Pacing QRS duration at 6 months after implantation Heart failure hospitalization and ventricular arrhythmia events after 2 years Adverse events after 2 years (lead dislodgement, lead re-implantation, lead fracture, device infection, lead perforation, bleeding, and all-cause death) | — |
Contacts
Department of Advanced Cardiovascular Therapeutics, Nagoya University Graduate School of Medicine