Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing

Atrioventricular Block Clinical Trial

— SEPTAL-PM  

Official title:

Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925691
• Other study ID #: RCB : 2008-A01027-48
• Secondary ID: LOC / 05-12
• Status: Completed
• Phase: Phase 3
• Start date: April 2010
• Est. completion date: May 2016

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrioventricular Block

Intervention

Device:
• RV lead
The RV lead is implanted at the apex or at the interventricular septum

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	Service de cardiologie-CHU de Brest	Brest
France	Service de cardiologie-CHU de Nantes	Nantes
France	CHU de Poitiers	Poitiers
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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 multicen — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction		18 months
Secondary	Quality of life questionnaire SF 36		18 months
Secondary	NYHA class		1, 6, 12, 18 months
Secondary	6-minute-walk test		1, 18 months
Secondary	LV end-systolic and diastolic volumes		18 months
Secondary	QRS duration,		1, 6, 12, 18 months
Secondary	Evolution of cardiac remodeling markers: MMP2-9 and TIMP-1 and NT-pro BNP dosage		18 months
Secondary	All causes and cardiovascular mortality, hospitalizations for cardiovascular cause		18 months
Secondary	Serious adverse events		18 months
Secondary	Stimulation and detection ventricular thresholds		1, 6, 12, 18 months
Secondary	Probes position and electric parameters		18 months