Heart and Blood Vessel Diseases
Conditions
Interventions
Case series:MVP ON and OFF
Sponsors
Medtronic
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Patient has symptomatic sinus node disease and QRS duration < 120ms and LV ejection fraction more than or equal to 45% by transthoracic echocardiography with standard pacing indication according to the current ACC/AHA/NASPE guidelines; 2. Patient has signed and dated study informed consent; 3. Patient is able to receive pectoral implant; 4. Patient will likely remain on a stable cardiac drug regimen, including anti-arrhythmic agents throughout the 12-month follow-up period.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Patient has co-existing second degree or complete heart block; 2. Patient has mechanical right heart valve; 3. Patients with permanent atrial fibrillation (AF); 4. Patient is under a minimum age as defined by local law; 5. Patient is enrolled in any concurrent study that would confound the results of this study; 6. Patient has a life expectancy of less than 12 months; 7. Women who are pregnant, or with child-bearing potential and who are not on a form of birth control; 8. Patient has had a heart transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Left Ventricular End Systolic Volume (LVESV)* at 12 months - Ejection Fraction * at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| - Tissue Dopplor Imaging (TDI) - Incidence of AF at 36 months - Heart Failure Hospitalization at 36 months - Mitral Valve Regurgitation Index* at 12 months - E/A ratio * at 12 months - SF-36 Health Survey Questionnaire at 36 months - BNP, ANP, N-terminal pro-BNP, epinephrine and norepinephrine levels (* by 2D echo); | — |
Countries
China
Contacts
Public ContactDr. Wing hong FUNG
Outcome results
None listed