Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| LOC / 05-12 | Other Identifier | Rennes University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The SEPTAL-PM study is aimed to compare the right ventricular apical and right ventricular septal position of the right ventricular lead in patients implanted with a pacemaker for conventional anti-bradycardia pacing indications requiring permanent right ventricular pacing ; the primary endpoint is the evolution of the left ventricular ejection fraction assessed by contrast echocardiography at 18-months follow-up.
Classically the right ventricular pacing (RV) lead position is the RV apex. Several small studies suggested that the septal position which provided a more physiological conduction pattern would improve left ventricular function and dimensions and the patients' outcome.
The SEPTAL-PM study is a parallel randomized prospective simple-blinded and multicenter national study with a follow-up duration of 18 month. A total of 180 patients will be enrolled.
It was designed to demonstrate that in patients requiring permanent RV pacing for high degree atrio-ventricular conduction disorders the septal pacing would preserve the LVEF and LV dimensions but also the quality of life and the exercise tolerance.
The primary endpoint is the evolution of the LVEF assessed by contrast echocardiography. The secondary endpoints are: the quality of life SF 36 questionnaire, the NYHA class, the 6-minute-walk test, the QRS duration, the LV end-systolic and diastolic volumes, the NT-pro BNP, MMP 2-9 and TIMP-1 dosages, stimulation and detection ventricular thresholds.
Other reported parameters are: the probes position and electric parameters, all causes of mortality, cardiovascular mortality, hospitalisations for cardiovascular causes, serious adverse events.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APICAL | Active Comparator | implantation at the apex |
|
| SEPTAL | Experimental | implantation at the interventricular septum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV lead | Device | The RV lead is implanted at the apex or at the interventricular septum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life questionnaire SF 36 | 18 months | |
| NYHA class | 1, 6, 12, 18 months | |
| 6-minute-walk test |
Not provided
Inclusion Criteria:
Non-inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christophe Leclercq, MD, PhD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Angers | 49000 | France | |||
| Service de cardiologie-CHU de Brest |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35221255 | Result | Galand V, Martins RP, Donal E, Behar N, Crocq C, Soulie GG, Degand B, Garcia R, Solnon A, Lande G, Probst V, Marjaneh F, Mansourati J, Dupuis JM, Laviolle B, Leclercq C. Septal versus apical pacing sites in permanent right ventricular pacing: The multicentre prospective SEPTAL-PM study. Arch Cardiovasc Dis. 2022 May;115(5):288-294. doi: 10.1016/j.acvd.2021.12.007. Epub 2022 Feb 19. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1, 18 months |
| LV end-systolic and diastolic volumes | 18 months |
| QRS duration, | 1, 6, 12, 18 months |
| Evolution of cardiac remodeling markers: MMP2-9 and TIMP-1 and NT-pro BNP dosage | 18 months |
| All causes and cardiovascular mortality, hospitalizations for cardiovascular cause | 18 months |
| Serious adverse events | 18 months |
| Stimulation and detection ventricular thresholds | 1, 6, 12, 18 months |
| Probes position and electric parameters | 18 months |
| Brest |
| 29000 |
| France |
| Service de cardiologie-CHU de Nantes | Nantes | 44000 | France |
| CHU de Poitiers | Poitiers | 86000 | France |
| CHU de Rennes | Rennes | 35000 | France |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |