Complete AV Block, Sick Sinus Syndrome
Conditions
Keywords
Left ventricular pacing
Brief summary
In this study, the investigators will examine whether left ventricular pacing is superior to right ventricular apical pacing in preventing deterioration of left ventricular systolic function and cardiac remodeling in patients with bradycardia with high risk for development of pacing-induced heart failure.
Detailed description
In this prospective, we will randomly assign 98 patients who need permanent pacemaker due to complete atrioventricular block or sick sinus syndrome to receive left ventricular pacing (49 patients) or right ventricular apical pacing (49 patients). Patients will be paced with temporary pacemaker lead, and only those with paced QRS duration ≥185 ms will be enrolled. The primary endpoint is left ventricular ejection fraction measured by modified Simpson method at 12 months. The secondary end points include left ventricular systolic end-systolic and diastolic volume, LV strain, NYHA functional class, exercise performance (using treadmill test), quality of life (using SF-36v2), NT-proBNP at 12 months.
Interventions
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
Inclusion criteria
* Sinus-node dysfunction or bradycardia due to advanced atrioventricular block * Paced QRS duration ≥185 ms
Exclusion criteria
* Left ventricular ejection fraction \< 50 % * Acute coronary syndrome * If they had undergone percutaneous coronary intervention or coronary-artery bypass surgery within the previous 3 months * if they had a life expectancy of less than 1 year * if they had received a heart transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular ejection fraction (%) at 12 months | 12 months | Measured by modified Simpson's method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular end-systolic volume (ml) at 12 months | 12 months | Measured by modified Simpson method |
| Left ventricular end-diastolic volume (ml) at 12 months | 12 months | Measured by modified Simpson method |
| NYHA functional class | 12 months | — |
| Functional capacity | 12 months | measured by treadmill test |
| NT-proBNP | 12 months | plasma level |
Countries
South Korea
Outcome results
None listed