To Pace or Not to Pace in Sinus Node Disease

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02485093

Acronym

OPTIMIST

Enrollment

215

Registered

2015-06-30

Start date

2009-06-30

Completion date

2014-10-31

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinus Node Disease

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.

Interventions

DEVICESeptal ventricular pacing

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

DEVICEVIP

Ventricular pacing must be less than 10%.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with sinus node disease

Exclusion criteria

* Complete or high degree AV block * Permanent atrial fibrillation

Design outcomes

Primary

Measure	Time frame
Left Ventricular Endsystolic Diameter (LVED)	18 months

Secondary

Measure	Time frame
AF incidence	18 months
Hospitalizations	18 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026