Clinical Trial: Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing

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 Summary:

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.


Sponsor: Rennes University Hospital

Current Primary Outcome: Left ventricular ejection fraction [ Time Frame: 18 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life questionnaire SF 36 [ Time Frame: 18 months ]
  • NYHA class [ Time Frame: 1, 6, 12, 18 months ]
  • 6-minute-walk test [ Time Frame: 1, 18 months ]
  • LV end-systolic and diastolic volumes [ Time Frame: 18 months ]
  • QRS duration, [ Time Frame: 1, 6, 12, 18 months ]
  • Evolution of cardiac remodeling markers: MMP2-9 and TIMP-1 and NT-pro BNP dosage [ Time Frame: 18 months ]
  • All causes and cardiovascular mortality, hospitalizations for cardiovascular cause [ Time Frame: 18 months ]
  • Serious adverse events [ Time Frame: 18 months ]
  • Stimulation and detection ventricular thresholds [ Time Frame: 1, 6, 12, 18 months ]
  • Probes position and electric parameters [ Time Frame: 18 months ]


Original Secondary Outcome:

  • SF 36 [ Time Frame: 18 months ]
  • NYHA class [ Time Frame: 18 months ]
  • 6-minute-walk test [ Time Frame: 18 months ]
  • LV end-systolic and diastolic volumes [ Time Frame: 18 months ]
  • QRS duration, [ Time Frame: 18 months ]
  • plasma concentration of MMP and 9 TIMPS and NT-pro BNP [ Time Frame: 18 months ]
  • All causes and cardiovascular mortality, hospitalizations for cardiovascular cause [ Time Frame: 18 months ]
  • Adverse events [ Time Frame: 18 months ]


Information By: Rennes University Hospital

Dates:
Date Received: June 18, 2009
Date Started: April 2010
Date Completion:
Last Updated: August 17, 2016
Last Verified: August 2016