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To 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
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinus Node Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 26, 2013
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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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

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To Pace or Not to Pace in Sinus Node Disease

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