NCT02485093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

4.1 years

First QC Date

July 26, 2013

Last Update Submit

February 1, 2019

Conditions

Sinus Node Disease

Outcome Measures

Primary Outcomes (1)

  • Left Ventricular Endsystolic Diameter (LVED)

    18 months

Secondary Outcomes (2)

  • AF incidence

    18 months

  • Hospitalizations

    18 months

Study Arms (2)

No pacing

ACTIVE COMPARATOR

Ventricular intrinsic conduction enhanced

Device: VIP

Pacing

EXPERIMENTAL

Septal ventricular pacing with optimized AV delay

Device: Septal ventricular pacing

Interventions

Septal ventricular pacingDEVICE

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

Pacing
VIPDEVICE

Ventricular pacing must be less than 10%.

No pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with sinus node disease

You may not qualify if:

  • Complete or high degree AV block
  • Permanent atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Pontchaillou - CCP

Rennes, 35000, France

Location

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, SinusArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesHeart BlockCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2013

First Posted

June 30, 2015

Study Start

June 1, 2009

Primary Completion

July 1, 2013

Study Completion

October 1, 2014

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

FR(1)