Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing (SEPTAL-PM)

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.

Study Overview

• Status: Completed
• Conditions: Atrioventricular Block
• Intervention / Treatment: Device: RV lead

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.

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Angers, France, 49000
    • CHU d'Angers
  • Brest, France, 29000
    • Service de cardiologie-CHU de Brest
  • Nantes, France, 44000
    • Service de cardiologie-CHU de Nantes
  • Poitiers, France, 86000
    • CHU de Poitiers
  • Rennes, France, 35000
    • CHU de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: APICAL; implantation at the apex	Device: RV lead; The RV lead is implanted at the apex or at the interventricular septum
Experimental: SEPTAL; implantation at the interventricular septum	Device: RV lead; The RV lead is implanted at the apex or at the interventricular septum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Left ventricular ejection fraction	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life questionnaire SF 36	18 months
NYHA class	1, 6, 12, 18 months
6-minute-walk test	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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Christophe Leclercq, MD, PhD, Rennes University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 18, 2009
• First Submitted That Met QC Criteria: June 19, 2009
• First Posted (Estimate): June 22, 2009

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Atrioventricular Block
• Other Study ID Numbers: RCB : 2008-A01027-48; LOC / 05-12 (Other Identifier: Rennes University Hospital)