Clinical trial NCT00925691: Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing
Official title: Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrioventricular Block
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2009-06-22
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years old.
* Written informed consent.
* Permanent cardiac pacing indication for high degree AV block with ventricular rate less than 50 bpm according to the current guidelines of the European Society of Cardiology .
* Patients with sinus rhythm or permanent atrial fibrillation.

Non-inclusion Criteria:

* Indication for cardiac resynchronization.
* Indication for Intra cardiac defibrillators (ICD).
* Indication for AV node ablation for patients with atrial fibrillation.
* Patients already implanted with a pacemaker or an ICD.
* Myocardial infarction within the previous month.
* Surgically treated valvulopathy.
* Tricuspid Valve prothesis
* Cardiac surgery or coronary revascularization planned or within the 3 last months.
* Life expectancy less than 18 months.
* Pregnancy.
* Disability to give informed consent.

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 18 months
Secondary outcomes:
measure: Quality of life questionnaire SF 36
timeFrame: 18 months
measure: NYHA class
timeFrame: 1, 6, 12, 18 months
measure: 6-minute-walk test
timeFrame: 1, 18 months
measure: LV end-systolic and diastolic volumes
timeFrame: 18 months
measure: QRS duration,
timeFrame: 1, 6, 12, 18 months
measure: Evolution of cardiac remodeling markers: MMP2-9 and TIMP-1 and NT-pro BNP dosage
timeFrame: 18 months
measure: All causes and cardiovascular mortality, hospitalizations for cardiovascular cause
timeFrame: 18 months
measure: Serious adverse events
timeFrame: 18 months
measure: Stimulation and detection ventricular thresholds
timeFrame: 1, 6, 12, 18 months
measure: Probes position and electric parameters
timeFrame: 18 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Brest
country: France
facility: Service de cardiologie-CHU de Brest
city: Nantes
country: France
facility: Service de cardiologie-CHU de Nantes
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Christophe Leclercq, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.