Trial on the effect of biventricUlar pacinG in patients with bradycardia prEserved LV functioN, with the aim of Decreasing Heart failure and ATrial fibrillation.
- Conditions
- AV block, Sick Sinus Syndrome - Bradycardia formCirculatory SystemSick Sinus Syndrome
- Registration Number
- ISRCTN04561582
- Lead Sponsor
- Olomouc University Hospital (Czech Rebublic)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method