AV block, Sick Sinus Syndrome - Bradycardia form Circulatory System Sick Sinus Syndrome
Conditions
Interventions
1. The study contains 120 patients randomized into right ventricular and biventricular pacing group with cross-over switch of pacing modes after six months
2. Standard descriptive statistics will be u
Sponsors
Olomouc University Hospital (Czech Rebublic)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Bradycardia pacing indication 2. Subject has stable medication (nitrates, diuretics, betablockers) within the last 3 months 3. Echocardiographic exclusion of ventricular (inter-and intra) dyssynchrony 4. Willing and able to comply with the Clinical investigation Plan 5. Signed Informed consent form 6. Aavailability for follow-up visits
Exclusion criteria
Exclusion criteria: 1. Age less 18 years 2. Indication for biventricular pacing 3. LV EF less than15% 4. Stable NYHA IV 5. Intravenous diuretics, ionotropics medication 6. Enrollment in a concurrent study that may confound the results of this study 7. Post heart transplant or awaiting heart transplantation 8. Renal insufficiency requiring dialiysis 9. Anticipation of poor compliance 10. Pregnancy 11. Life expectancy less than 12 months 12. The inform consent form not signed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Electrocardiographic parameters (ECG) 2. Echocardiographic parameters (LV Ejection Fraction) 3. Evaluation of NYHA class 4. Evaluation of Quality of Live (Minnesota Living with Heart Failure questionnaire) | — |
Secondary
| Measure | Time frame |
|---|---|
| Atrial Fibrillation burden hospitalization for Heart Failure complication of pacing | — |
Countries
Czech Republic
Outcome results
None listed