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

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Abbott

Status

Completed

Conditions

Sinus Node Disease

Treatments

Device: Septal ventricular pacing
Device: VIP

Study type

Interventional

Funder types

Industry

Identifiers

NCT02485093
2008-A01266-49

Details and patient eligibility

About

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.

Enrollment

215 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with sinus node disease

Exclusion criteria

  • Complete or high degree AV block
  • Permanent atrial fibrillation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

215 participants in 2 patient groups

No pacing
Active Comparator group
Description:
Ventricular intrinsic conduction enhanced
Treatment:
Device: VIP
Pacing
Experimental group
Description:
Septal ventricular pacing with optimized AV delay
Treatment:
Device: Septal ventricular pacing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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