Right Ventricular Outflow Tract Study (RVOTCARE)
Sinus-node Dysfunction
About this trial
This is an interventional treatment trial for Sinus-node Dysfunction focused on measuring sinus-node dysfunction, RVOTs pacing, RVA pacing
Eligibility Criteria
Inclusion Criteria:
- Patients with only sinus-node dysfunction and meet pacing indication
- Patients with LVEF≥60% and with ventricular synchrony.
- Patients signed the written informed consent for the study
- Patients can endure the required follow up
Exclusion Criteria:
- Patients with atrial fibrillation
- Patients with atrial-ventricular block
- Patients with LBBB
- Patients with significant valvular disease
- Patients with severe hematopathy or severe renal inadequacy
- Patients with life expectancy < 1.5 year
- Patients who are in the period of pregnant or lactation
- Patients who are younger than 18 years old
- Patients who are ongoing other devices or agents study
Sites / Locations
- Guang Dong General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
RVOTs
AAI
RVA
555 Patients will be randomized to three groups(RVOTs, RVA, AAI) in 1:1:1, 185 patients in RVOTs arm, the RV lead of this group patients will be implanted in right ventricular outflow tract septum,the accumulated ventricular pacing percentage should be over 80% by adjusting AV delays.
555 Patients will be randomized to three groups(RVOTs, RVA, AAI) in 1:1:1, 185 patients in AAI arm, the RV lead of this group patients will be implanted in right ventricular apex.
555 Patients will be randomized to three groups(RVOTs, RVA, AAI) in 1:1:1, 185 patients in RVA arm, the RV lead of this group patients will be implanted in right ventricular apex, the accumulated ventricular pacing percentage should be over 80% by adjusting AV delays.