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

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

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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