NCT01477138Unknown不适用
Comparison of Right Ventricular Septal Pacing to Minimized Right Ventricular Septal Stimulation in Patients With Sick Sinus Syndrome
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- end-systolic LV volume
研究概览
简要总结
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:
- Prospective, monocentric, randomized, double-blinded
- Run-in phase: for weeks AAI [R]-DDD [R]
- Randomization: two groups A) septal right ventricular chamber pacing: mode DDD [R] versus B) Reduction of unnecessary ventricular pacing: AAI [R]-DDD [R].
- FU: 6 and 12-months
Primary endpoints:
-LV ejection fraction and end-systolic LV volume after 12 months.
Secondary endpoints:
-LV end-diastolic volume, TAPSE, parameters of dyssynchrony (SPWMD, LV-PEP, IVMD), AF-burden, % ventricular pacing, CPX: peak oxygen consumption (peak VO2), VO2 AT, VO2/HR, VE/VCO2 slope; QoL scores (SF-36) after 12 months.
Statistics/sample size estimation:
In order to detect a difference in LVEF of 5% and for LV-ESV of 5 mL between the 2 groups after 12 months:
-
90% power/alpha 5%: 84 patients per group
-
80% power/alpha 5%: 63 patients per group
-
10% for compensation of drop-outs / patients lost of follow-up. Two-sided 5% type 1 error Analysis intention-to-treat and based on the finally programmed pacing mode.
Material
- PG: market released dual chamber pacemakers with the ability to pace AAI(R) -DDD(R)
- pacing leads: market-released standard active electrodes
- RV electrode: septal verified under multi-level screening (RAO/LAO) and ECG (LBBB narrow <150 ms / inferior axis)
详细描述
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 right ventricular septal pacing in patients with SSS
Inclusion criterion:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pacemaker indication according to current guidelines: sick sinus syndrome (SSS)
排除标准
- •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
结局指标
主要结局
end-systolic LV volume
时间窗: at randomisation and after 12 months
left ventricular ejection fraction (LV-EF)
时间窗: at randomisation and after 12 months
TTE, Simpson, biplane
次要结局
- TAPSE(at randomisation and after 12 months)
- echocardiographic parameter of dyssynchrony(at randomisation and after 12 months)
- peak VO2, VO2 AT, VO2/HR, VE/VCO2 slope(at randomisation and after 12 months)
- quality of life-scores(at randomisation and after 12 months)
- AF burden(at randomisation and after 12 months)
- % ventricular pacing(at randomisation and after 12 months)
- LV end diastolic volume(at randomisation and after 12 months)
研究者
Natalia Rohr
Natalia Rohr
Klinikum Nürnberg
研究点 (1)
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