An interventional study of Permanent Cardiac Pacemaker Implantation in Bradycardia, Heart Block and Sick Sinus Syndrome, sponsored by Ospedale Santa Maria di Loreto Mare. Status unknown at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-23.
Sponsored by Ospedale Santa Maria di Loreto Mare · Not applicable, Interventional, and Prevention
This study is a long-term, prospective, and controlled evaluation of the mechanical dyssynchrony induced by right ventricular apical pacing, both in acute (spontaneous and stimulated) and chronic (12 and 24 months); the study also evaluates the benefit of an alternative pacing site through measures of dyssynchrony in acute and chronic.
Permanent cardiac pacing plays an important role in cardiac disease management. Since early studies on right ventricular pacing, apex has been the preferred implant site for transvenous endocardial ventricular leads for several reasons: ease of placement, lead stability as well as the design characteristics of the electrode and the fixation system.
It is now also accepted, however, that right ventricle pacing causes a long term deterioration of left ventricular function through complex effects, both at the structural level of the heart wall and at the hemodynamic level in left ventricular load conditions. It is possible that this deterioration is due to a dyssynchrony of contraction induced by pacing at the right ventricular apex. Some authors suggest to pace the right ventricle at alternative sites, i.e. the medium septum (RVS) region, to guarantee a more physiological activation pattern, especially in patients expected to receive high pacing percentages.
However, unequivocal evidences that stimulation of the right ventricular septum is more physiological than the apical pacing are still missing.
Nonetheless, it should be noted that, although a number of studies refer to RV septum as the alternative site for pacing , poor attention has been paid to the unambiguous definition of RV septum region itself. A clear definition and a proper evaluation of the alternative site is therefore important.
Furthermore, from a procedural point of view, it has been demonstrated that acute and chronic electrical performances of the leads positioned at alternative sites, in particular in the region of mid septum, are equivalent to those of the leads positioned at the apical site.
The purpose of this study is to perform a comprehensive assessment of the electrical and mechanical measures obtained by pacing standard RV site (Right ventricular apex, RVA) and alternative RV site (right ventricular septum, RVS). Specifically, the two pacing sites will be compared in terms of electrical dyssynchrony, as assessed by ECG criteria, and in terms of mechanical dyssynchrony, as assessed by echocardiographic criteria.
The primary end point of the study is defined through the evaluation of dyssynchrony measured both in spontaneous rhythm (Vs) and paced rhythm (Vp). The delay between the time to peak systolic velocity of the septum and the LV free wall will be used to define the degree of dyssynchrony; this measurement will be obtained by TDI echocardiographic technique.
Patients will receive any commercially available dual-chamber implantable pacemakers, according to current standard indications. At the end of the implantation and at follow-up visits (12 and 24 months) device programming will follow the clinical practice of the center.
306 studies on the registry are indexed under Bradycardia; 69 are open to participants now.
This study's planned enrollment of 408 is above the median of 99 across 174 interventional studies indexed under Bradycardia.
Browse Bradycardia studies →Ospedale Santa Maria di Loreto Mare is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
In the RVA group the right ventricular pacing lead will be implanted in the apex region of the right ventricle
Procedure: Permanent Cardiac Pacemaker Implantation
In the RVS group the right ventricular pacing lead will be implanted in the septal region (mid septum) of the right ventricle
Procedure: Permanent Cardiac Pacemaker Implantation
LV dyssynchrony as measured by Electromechanical delay (EMD
The primary outcome measure of this study is to compare the effect of RV Septal (RVS) versus RV Apical (RVA) pacing as measured by echocardiographic/Doppler Index
Time frame: 2 weeks
Number of heart failure-related hospitalization
To compare the rate of heart failure-related hospitalization between RVS versus RVA pacing
Time frame: 24 months
Right ventricular lead and total implant procedure time, fluoroscopy time
To compare the procedural time of RVS versus RVA pacing
Time frame: Implant
Change from baseline in R wave in 12-lead ECG
To investigate the relationship between the ECG characteristics at baseline and response to cardiac pacing (as measured by echocardiography as defined in primary outcome measure) at implant and 24 months
Time frame: 24 months
Absolute change in LVEF
To evaluate the Left ventricular diastolic and systolic function as measured by Echocardiographic response of absolute change in LVEF
Time frame: 24 months
LV dyssynchrony as measured by Electromechanical delay (EMD)
The secondary outcome measure of this study is to compare the effect of RVS versus RVA pacing as measured by echocardiographic/Doppler Index. This extends to 24 months the results obtained with the primary objective at 2 weeks
Time frame: 24 months
Symptoms and quality of life scores
To investigate the relationship between the right ventricular lead position and response to cardiac pacing in terms of symptoms and quality of life scores as measured by short form (SF)-12 scores
Time frame: 24 months
This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Ospedale Santa Maria di Loreto Mare