Health Condition 1: null- Heart block and left ventricular ejection fraction more than 45%
Conditions
Interventions
Intervention1: CRT- Pacemaker: A St. Jude Medical cardiac resynchronization therapy pacemaker (CRT-P) Frontier II
5596 or a more recent CE marked CRT-P with similar capabilities.
Control Intervention1
Sponsors
SJM International Inc
St Jude Medical India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patient meets current indications for implantation of a DDDR pacemaker Patient is geographically stable and willing to comply with the required follow-up schedule Patient has LVEF greater than 45% Patient has atrioventricular block (IIo or above) Patient has adequate echocardiographic images to measure LV volumes and LV ejection fraction
Exclusion criteria
Exclusion criteria: Patient has permanent atrial fibrillation (AF) Patient has unstable angina or an acute coronary syndrome Patient has undergone percutaneous coronary intervention or coronary artery bypass surgery within the previous 3 months Patient life expectancy is less than 1 year Patient is less than 18 years old Patient is pregnant Patient has received a heart transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LVEF for assessment of LV systolic function LV end-systolic volume LVESV) for assessment of LV remodelingTimepoint: Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| NYHA Class Assessment; Left Ventricular End Diastolic Volume & 6 Minute Hall Walk testTimepoint: Month 12 | — |
Countries
Hong Kong, India, Italy, United Kingdom
Contacts
Public ContactSumit Anand
St. Jude Medical India Pvt. Ltd
Outcome results
None listed