To Pace or Not to Pace in Sinus Node Disease

Not Applicable

Completed

• Conditions: Sinus Node Disease
• Interventions: Device: VIP; Device: Septal ventricular pacing

• Registration Number: NCT02485093
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2013-07
• Study First Submitted: 2013-07-26
• Study Completion: 2014-10
• Study First Submitted QC: 2015-06-29
• Study First Posted: 2015-06-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

• Patients with sinus node disease

Exclusion Criteria

• Complete or high degree AV block
• Permanent atrial fibrillation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No pacing	VIP	Ventricular intrinsic conduction enhanced
Pacing	Septal ventricular pacing	Septal ventricular pacing with optimized AV delay

Primary Outcome Measures

Name	Time	Method
Left Ventricular Endsystolic Diameter (LVED)	18 months

Secondary Outcome Measures

Name	Time	Method
Hospitalizations	18 months
AF incidence	18 months

Trial Locations

Locations (1)

CHU Pontchaillou - CCP; 🇫🇷 Rennes, France