First Degree Atrioventricular Block., Sinus Node Disease.
Conditions
Brief summary
The aim of this study is to evaluate the effect of minimizing right ventricular pacing in dual-chamber pacemaker patients with sinus node disease (SND) and first degree atrioventricular block (AVIB)on exercise capacity, quality of life and other heart failure measures.
Interventions
DEVICEProlonging atrioventricular (AV) delay.
Prolonging atrioventricular (AV) delay to maximum 350 ms.
DEVICEStandard atrioventricular (AV) delay.
Standard atrioventricular (AV) delay - approximately 180/140 ms depending on heart rate.
Sponsors
Military Institute od Medicine National Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* prolonged PQ interval \> 200 ms, * percentage of right ventricular pacing with standard AV delay \> 90.
Exclusion criteria
* second or third degree atrioventricular block, * permanent atrial fibrillation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxygen uptake (cardiopulmonary exercise testing). | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular ejection fraction. | 3 months | Assessed in echocardiography. |
| Quality of life | 3 months | SF36 questionnaire. |
| Arrhythmia | 3 months | 24 hours Holter monitoring, pacemaker storage data. |
| Ventilatory anaerobic threshold (cardiopulmonary exercise testing) | 3 months | — |
| VE/VCO2 slope (cardiopulmonary exercise testing). | 3 months | — |
Countries
Poland
Contacts
Primary ContactKrystian Krzyżanowski, MD
Outcome results
None listed