Back to resultsTo Pace or Not to Pace in Sinus Node Disease (OPTIMIST)
Primary Purpose
Sinus Node Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Septal ventricular pacing
VIP
Sponsored by
About this trial
This is an interventional treatment trial for Sinus Node Disease
Eligibility Criteria
Inclusion Criteria:
- Patients with sinus node disease
Exclusion Criteria:
- Complete or high degree AV block
- Permanent atrial fibrillation
Sites / Locations
- CHU Pontchaillou - CCP
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
No pacing
Pacing
Arm Description
Ventricular intrinsic conduction enhanced
Septal ventricular pacing with optimized AV delay
Outcomes
Primary Outcome Measures
Left Ventricular Endsystolic Diameter (LVED)
Secondary Outcome Measures
AF incidence
Hospitalizations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02485093
Brief Title
To Pace or Not to Pace in Sinus Node Disease
Acronym
OPTIMIST
Official Title
Comparison of Ventricular Septal Pacing With Optimized Atrioventricular (AV) Delay to no Pacing in Sinus Node Disease (SND) Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinus Node Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
215 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No pacing
Arm Type
Active Comparator
Arm Description
Ventricular intrinsic conduction enhanced
Arm Title
Pacing
Arm Type
Experimental
Arm Description
Septal ventricular pacing with optimized AV delay
Intervention Type
Device
Intervention Name(s)
Septal ventricular pacing
Intervention Description
Ventricular pacing must be at least 90%, from the septum and with optimized AV delay
Intervention Type
Device
Intervention Name(s)
VIP
Intervention Description
Ventricular pacing must be less than 10%.
Primary Outcome Measure Information:
Title
Left Ventricular Endsystolic Diameter (LVED)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
AF incidence
Time Frame
18 months
Title
Hospitalizations
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with sinus node disease
Exclusion Criteria:
Complete or high degree AV block
Permanent atrial fibrillation
Facility Information:
Facility Name
CHU Pontchaillou - CCP
City
Rennes
ZIP/Postal Code
35000
Country
France
12. IPD Sharing Statement
Learn more about this trial
To Pace or Not to Pace in Sinus Node Disease
We'll reach out to this number within 24 hrs