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OpenTrials
Completed

NCT Number: NCT02485093

To Pace or Not to Pace in Sinus Node Disease

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.

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Key information

Conditions

Sinus Node Disease Arrhythmia, Sinus Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sick Sinus Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Pontchaillou - CCP

Rennes, 35000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with sinus node disease

Exclusion criteria

  • Complete or high degree AV block
  • Permanent atrial fibrillation

Treatment and study plan

Septal ventricular pacing

Device

Ventricular pacing must be at least 90%, from the septum and with optimized AV delay

VIP

Device

Ventricular pacing must be less than 10%.

Primary outcomes

  1. Left Ventricular Endsystolic Diameter (LVED)

    Time frame: 18 months

Secondary outcomes

  1. AF incidence

    Time frame: 18 months

  2. Hospitalizations

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: OPTIMIST

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Jun 30, 2015
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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