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].
- 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
- 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
Aim:
- to evaluate chronic effects of proven right ventricular septal compared to minimized righ
Sponsor: Klinikum Nürnberg
Current Primary Outcome:
Original Primary Outcome: Same as current
Current Secondary Outcome:
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