Bradycardia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: a. Consecutive patients who received pacemaker implantation due to bradycardia according to the current guideline (Class I and IIa recommendation); b. left ventricular ejection fraction(LVEF) over 50% c. Consent form signed; d. Aged 18-90 years old.
Exclusion criteria
Exclusion criteria: a. Implanted implantable cardioverter-defibrillator; b. Received biventricular pacing; c. Previous tricuspid annuloplasty history; d. Pregnancy; e. Unwilling to be followed-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of composite outcomes, including all-cause death, hospitalization for heart failure, and an upgrade to cardiac resynchronization therapy due to pacing induced heart failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of composite outcomes of all-cause death and/or hospitalization for heart failure;The rate of composite outcomes of hospitalization for heart failure and/or an upgrade to cardiac resynchronization therapy due to pacing induced heart failure. ;The rate of composite outcomes of LVEF <50%, and/or an increase in LVESV =15% during follow-up as compared with the value at randomization;The value of LVEF and LVESV assessed by echocardiography ;The immediate success rate of the pacing procedure;Rate of procedure and Device related complications;Rate of atrial high-rate episodes recorded by the pacemaker;Rate of tricuspid regurgitation during the follow up;Pacing characteristics;Electrophysiological parameters;Echocardiographic measurements; | — |
Countries
China
Contacts
Fuwai Hospital, Chinese Academy of Medical Sciences