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CompletedNCT01169896FIRSTUpdated Dec 3, 2015

Impact of Ventricular Pacing in Unselected ICD/CRT-D Patients

An observational study in Ventricular Tachycardia and Ventricular Fibrillation, sponsored by LivaNova. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-03.

Sponsored by LivaNova · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
616
Ages
18 Years and older
Sex
All
01

Study summary

Observational study is evaluating Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) thérapies as a function of ventricular pacing

Read the detailed description

This protocol consists in a non-interventional multi-centre, prospective study. The observational study will also answer the question of the impact of ventricular pacing on the outcome of patients implanted with ICD \& CRT-D devices and how the ICD \& CRT-D devices are used in clinical practice through two years follow-up.

02

Conditions studied

  • Ventricular Tachycardia
  • Ventricular Fibrillation

Keywords

  • Impact of ventricular pacing on the incidence of VT/VF episodes for each models
03

In context

Tachycardia

623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.

This study's enrollment of 616 is above the median of 149 across 208 observational studies indexed under Tachycardia.

Browse Tachycardia studies →

Lead sponsor

LivaNova is the lead sponsor of 39 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

unselected ICD/CRT-D implanted patients

Eligibility criteria

Main inclusion Criteria:

•Patient implanted (primo implantation or replacement) with an ICD (OVATIO VR 6250, DR 6550, CRT 6750 models, or any similar or higher range device, that includes specific diagnostic and therapeutic functionalities, mandatory to make homogeneous the collection of data)

Main exclusion Criteria:

  • Presence of a contra-indication to the ICD therapy.
  • Life expectancy less than 12 months.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
616 participants (actual)
06

What researchers measure

Primary outcomes

  1. VT/VF episodes according to ventricular pacing (> and <50%)

    Device-based data

    Time frame: 2 years

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Study locations

1 site
  • CCN
    St Denis, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01169896
Lead sponsor
LivaNova
Responsible party
Sponsor
First posted
Jul 26, 2010
Start date
Nov 2007
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Dec 3, 2015

Study contacts

Olivier Piot, MD
principal investigator · CCN St Denis

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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