NCT01169896

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
616

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

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

November 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

4.1 years

First QC Date

July 22, 2010

Last Update Submit

December 2, 2015

Conditions

Ventricular TachycardiaVentricular Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

    Device-based data

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

unselected ICD/CRT-D implanted patients

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CCN

Saint-Denis, France

Location

MeSH Terms

Conditions

Tachycardia, VentricularVentricular Fibrillation

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Piot, MD

    CCN St Denis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 26, 2010

Study Start

November 1, 2007

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

FR(1)