Not provided
Not provided
Not provided
Not provided
Slow enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare chronic (1-year) effects on left ventricular ejection fraction resulting from transvenous pacing of the right ventricular apex (RVA) versus the left ventricular apex (LVA) in patients with preserved or mildly reduced left ventricular systolic function (>= 45%).
It is well established that chronic right ventricular apical pacing has an adverse effect on left ventricular systolic function. An alternative is pacing the left ventricular apex, which has shown more favourable results in terms of left ventricular pump function than the RVA in small series. The left ventricular apex may be paced via the coronary sinus tributary (e.g. in the anterior cardiac vein). Our study will compare effects of these two pacing sites on left ventricular ejection fraction measured by 3D-echocardiography.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right ventricular apex pacing | Active Comparator |
| |
| Left ventricular apex pacing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing | Device | Implantation procedure for a St-Jude Medical pacemaker system with a transvenous ventricular and if applicable a right atrial lead |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in LVEF | baseline to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular end-systolic and end-diastolic volumes | one year | |
| Dyssynchrony evaluation during RV and LV pacing | one year | |
| Change in tricuspid regurgitation severity, if any |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Haran Burri, Assoc. Prof. | University Hospital, Geneva | Principal Investigator |
| Angelo Auricchio, Prof. | Fondazione Cardiocentro Ticino (Lugano) | Principal Investigator |
| Christian Sticherling, Prof. | University Hospital of Basel | Study Chair |
| Paul Erne, Prof. | Luzerner Kantonsspital | Study Chair |
| Peter Ammann, PD Dr. | Cantonal Hospital of St. Gallen | Study Chair |
| Frits Prinzen, Dr. | Cardiovascular Research Institute, University of Maastricht | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Research Institute, University of Maastricht | Maastricht | 6229 | Netherlands | |||
| University Hospital of Basel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing | Device | Implantation procedure for a St-Jude Medical pacemaker system with a transvenous left ventricular (coronary sinus) and if applicable a right atrial lead |
|
| one year |
| Change in mitral regurgitation severity, if any | one year |
| Incidence of device-related complications | one year |
| Success rate of autocapture algorithm for left-and right-ventricular pacing | one year |
| Mortality and all cause hospitalization | one year |
| Reduction of LVEF at 1 year compared to baseline according to the following pre-specified subgroups: a) initial LVEF, b) gender, c)etiology (coronary artery disease, nonischemic cardiomyopathy) | one year |
| Basel |
| Canton of Basel-City |
| 4031 |
| Switzerland |
| University Hospital Geneva | Geneva | Canton of Geneva | 1211 | Switzerland |
| Kantonsspital Luzern | Lucerne | Canton of Lucerne | 6000 | Switzerland |
| Kantonsspital St-Gallen | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| Cardiocentro Ticino (Lugano) | Lugano | Canton Ticino | 6900 | Switzerland |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D016254 | Mutagenesis, Insertional |
| ID | Term |
|---|---|
| D015202 | Protein Engineering |
| D005818 | Genetic Engineering |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D009154 | Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D016296 | Mutagenesis |
Not provided
Not provided