Clinical Trial: To Pace or Not to Pace in Sinus Node Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparison of Ventricular Septal Pacing With Optimized Atrioventricular (AV) Delay to no Pacing in Sinus Node Disease (SND) Patients.
Brief Summary:
Optimal pacing strategy for patients with SND is still unknown, although several publications in the past years demonstrated a deleterious effect of ventricular pacing. However, pacing has always been apical in these trials, and to which extent this absence of pacing is beneficial for patients with very long PR intervals is still to be found.
The aim of this study is to compare ventricular septal pacing to no pacing in patients with SND.
Detailed Summary:
Sponsor: St. Jude Medical
Current Primary Outcome: Left Ventricular Endsystolic Diameter (LVED) [ Time Frame: 18 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- AF incidence [ Time Frame: 18 months ]
- Hospitalizations [ Time Frame: 18 months ]
Original Secondary Outcome: Same as current
Information By: St. Jude Medical
Dates:
Date Received: July 26, 2013
Date Started: June 2009
Date Completion:
Last Updated: June 29, 2015
Last Verified: June 2015