Clinical Trial: Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of Apical and Alternative Position

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of Apical and Alternative Position - Right Pace Study

Brief Summary: 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.

Detailed Summary:

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 o
Sponsor: Ospedale Santa Maria di Loreto Mare

Current Primary Outcome: LV dyssynchrony as measured by Electromechanical delay (EMD [ Time Frame: 2 weeks ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of heart failure-related hospitalization [ Time Frame: 24 months ]
    To compare the rate of heart failure-related hospitalization between RVS versus RVA pacing
  • Right ventricular lead and total implant procedure time, fluoroscopy time [ Time Frame: Implant ]
    To compare the procedural time of RVS versus RVA pacing
  • Change from baseline in R wave in 12-lead ECG [ Time Frame: 24 months ]
    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
  • Absolute change in LVEF [ Time Frame: 24 months ]
    To evaluate the Left ventricular diastolic and systolic function as measured by Echocardiographic response of absolute change in LVEF
  • LV dyssynchrony as measured by Electromechanical delay (EMD) [ Time Frame: 24 months ]
    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
  • Symptoms and quality of life scores [ Time Frame: 24 months ]
    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


Original Secondary Outcome: Same as current

Information By: Ospedale Santa Maria di Loreto Mare

Dates:
Date Received: July 19, 2012
Date Started: April 2012
Date Completion: July 2015
Last Updated: July 19, 2012
Last Verified: July 2012