To Pace or Not to Pace in Sinus Node Disease (OPTIMIST)
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|ClinicalTrials.gov Identifier: NCT02485093|
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : February 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Sinus Node Disease||Device: Septal ventricular pacing Device: VIP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||215 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison of Ventricular Septal Pacing With Optimized Atrioventricular (AV) Delay to no Pacing in Sinus Node Disease (SND) Patients.|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||October 2014|
Active Comparator: No pacing
Ventricular intrinsic conduction enhanced
Ventricular pacing must be less than 10%.
Septal ventricular pacing with optimized AV delay
Device: Septal ventricular pacing
Ventricular pacing must be at least 90%, from the septum and with optimized AV delay
- Left Ventricular Endsystolic Diameter (LVED) [ Time Frame: 18 months ]
- AF incidence [ Time Frame: 18 months ]
- Hospitalizations [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485093
|CHU Pontchaillou - CCP|
|Rennes, France, 35000|