Clinical Trial: RV Septal Versus Minimized RV Pacing in Sick Sinus Syndrome

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Comparison of Right Ventricular Septal Pacing to Minimized Right Ventricular Septal Stimulation in Patients With Sick Sinus Syndrome

Brief Summary:

Background:

  • Potential negative effects of pacing in the RV-apex are well documented
  • However, study results comparing septal / RVOT-pacing versus RV-apical pacing controversial.
  • The optimal pacing mode in SSS (DDDR versus AAIR) is unclear, as the DDD (R) mode with an AV delay ≤ 220 ms should be the preferred pacing mode, according to the DANPACE trial [DANPACE, ESC 2010, Stockholm].

Aim:

- to evaluate chronic effects of proven right ventricular septal compared to minimized right ventricular septal pacing in patients with SSS

Inclusion criterion:

-Pacemaker indication according to current guidelines: sick sinus syndrome (SSS)

Exclusion criteria:

  • Life expectancy < 2 years
  • Age <18 years
  • Noncompliance with regard to participation in the study
  • Pregnancy
  • AV block ° 2 and higher
  • Permanent atrial fibrillation
  • Heart failure NYHA III and IV, reduced LV-EF <40%
  • ICD indication
  • Acute coronary syndrome. PCI or CABG <3 months
  • Heart transplant
  • Placement of septal RV electrode is not possible

Study design:

    Background:

    • Potential negative effects of pacing in the RV-apex are well documented
    • Asynchronous ventricular activation
    • reduction of systolic and diastolic LV function
    • Experimental data: histological changes
    • Asymmetric LV hypertrophy and thinning
    • However, study results comparing septal / RVOT-pacing versus RV-apical pacing controversial:
    • Acute versus chronic
    • Small number of cases, uncontrolled, unblinded,
    • Brief periods of observation in the cross-over design (3 months)
    • "RVOT" often summarizes different stimulation sites: high RVOT, lateral, septal. Actually only limited data with proven septal stimulation
    • No objective performance assessment (CPX)
    • Assessment of alternative stimulation site previously RVOT versus RV-apex,
    • ventricular pacing compared to ventricular pacing, then tested a potential harm to another
    • The question of the optimal pacing mode of patients with SSS (DDDR versus AAIR) appears to be open again. While in Germany, two-chamber systems with AAI [R] mode with ventricular back-up are used, should the DDD (R) mode with an AV delay ≤ 220 ms be the preferred pacing mode, according to the results of the DANPACE trial for patients with SSS [DANPACE, ESC 2010, Stockholm].

    Aim:

    - to evaluate chronic effects of proven right ventricular septal compared to minimized righ
    Sponsor: Klinikum Nürnberg

    Current Primary Outcome:

    • end-systolic LV volume [ Time Frame: at randomisation and after 12 months ]
    • left ventricular ejection fraction (LV-EF) [ Time Frame: at randomisation and after 12 months ]
      TTE, Simpson, biplane


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • TAPSE [ Time Frame: at randomisation and after 12 months ]
    • echocardiographic parameter of dyssynchrony [ Time Frame: at randomisation and after 12 months ]
      TTE, SPWMD, LV-PEP, IVMD
    • peak VO2, VO2 AT, VO2/HR, VE/VCO2 slope [ Time Frame: at randomisation and after 12 months ]
      CPX: cardiopulmonary exercice testing
    • quality of life-scores [ Time Frame: at randomisation and after 12 months ]
      SF-36
    • AF burden [ Time Frame: at randomisation and after 12 months ]
    • % ventricular pacing [ Time Frame: at randomisation and after 12 months ]
    • LV end diastolic volume [ Time Frame: at randomisation and after 12 months ]
      TTE


    Original Secondary Outcome: Same as current

    Information By: Klinikum Nürnberg

    Dates:
    Date Received: July 5, 2011
    Date Started: July 2011
    Date Completion: December 2013
    Last Updated: November 18, 2011
    Last Verified: November 2011