To Pace or Not to Pace in Sinus Node Disease (OPTIMIST)

February 1, 2019 updated by: Abbott Medical Devices

Comparison of Ventricular Septal Pacing With Optimized Atrioventricular (AV) Delay to no Pacing in Sinus Node Disease (SND) Patients.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35000
        • CHU Pontchaillou - CCP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with sinus node disease

Exclusion Criteria:

  • Complete or high degree AV block
  • Permanent atrial fibrillation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: No pacing
Ventricular intrinsic conduction enhanced
Device: VIP
Ventricular pacing must be less than 10%.
Experimental: Pacing
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left Ventricular Endsystolic Diameter (LVED)
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
AF incidence
Time Frame: 18 months
18 months
Hospitalizations
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

June 29, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-A01266-49

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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