Clinical Trial: Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance

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

Official Title: Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance

Brief Summary: The study aims to use cardiac MRI scans and analysis techniques to evaluate differences in cardiac function after 12 months of pacing in patients with pacing leads placed in different positions within the right ventricle (apically or septally).

Detailed Summary:

Prolonged pacing from the right ventricular (RV) Apex has been shown to be associated with progressive left ventricular (LV) dysfunction. This has led to an interest in alternative right ventricular pacing sites. Only very few studies investigated the effect of alternative right ventricular pacing sites using three dimensional imaging. Using cardiac MRI volumetric left- and right ventricular analysis and three-dimensional reconstruction is more accurate compared to trans-thoracic echocardiogram. St. Jude Medical has developed a MRI conditional pacemaker system enabling for the first time to investigate alternative pacing sites using cardiac MRI.

Patients already implanted with an MRI conditional pacemaker system from St. Jude Medical will be enrolled in that study and subdivided into 4 groups (right ventricular pacing lead positioned apically or septally subdivided in patients paced for <50% of time or 50% or more). All patients will undergo cardiac MRI at enrollment and again 12 months later. Patients paced <50% of the time will undergo cardiac MRI with and without pacemaker stimulation at both visits.


Sponsor: St. Jude Medical

Current Primary Outcome: Change in LV chamber volumes. [ Time Frame: 12 months (baseline to end of study) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Dyssynchrony [ Time Frame: 12 months ]
  • Change in Ejection fraction [ Time Frame: 12 months ]
  • Change in Strain rate [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: St. Jude Medical

Dates:
Date Received: February 21, 2013
Date Started: January 2013
Date Completion: September 2016
Last Updated: May 3, 2016
Last Verified: May 2016