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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00925691
First received: June 18, 2009
Last updated: March 18, 2014
Last verified: March 2014

June 18, 2009
March 18, 2014
April 2010
April 2015   (final data collection date for primary outcome measure)
Left ventricular ejection fraction [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00925691 on ClinicalTrials.gov Archive Site
  • Quality of life questionnaire SF 36 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • NYHA class [ Time Frame: 1, 6, 12, 18 months ] [ Designated as safety issue: No ]
  • 6-minute-walk test [ Time Frame: 1, 18 months ] [ Designated as safety issue: No ]
  • LV end-systolic and diastolic volumes [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • QRS duration, [ Time Frame: 1, 6, 12, 18 months ] [ Designated as safety issue: No ]
  • Evolution of cardiac remodeling markers: MMP2-9 and TIMP-1 and NT-pro BNP dosage [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • All causes and cardiovascular mortality, hospitalizations for cardiovascular cause [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Stimulation and detection ventricular thresholds [ Time Frame: 1, 6, 12, 18 months ] [ Designated as safety issue: No ]
  • Probes position and electric parameters [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • SF 36 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • NYHA class [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • 6 minute walk test [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • LV end-systolic and diastolic volumes [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • QRS duration, [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • plasma concentration of MMP and 9 TIMPS and NT-pro BNP [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • All cause and cardiovascular mortality, hospitalization for cardiovascular cause [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing
Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Atrioventricular Block
Device: RV lead
The RV lead is implanted at the apex or at the interventricular septum
  • Active Comparator: APICAL
    implantation at the apex
    Intervention: Device: RV lead
  • Experimental: SEPTAL
    implantation at the interventricular septum
    Intervention: Device: RV lead
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
October 2016
April 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Christophe Leclercq, MD, PhD christophe.leclercq@chu-rennes.fr
France
 
NCT00925691
RCB : 2008-A01027-48, LOC / 05-12
No
Rennes University Hospital
Rennes University Hospital
Not Provided
Principal Investigator: Christophe Leclercq, MD, PhD Rennes University Hospital
Rennes University Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP