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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

616 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Ventricular Tachycardia Ventricular Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Piot, MD

Role: PRINCIPAL_INVESTIGATOR

CCN St Denis

Locations

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CCN

Saint-Denis, , France

Site Status

Countries

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France

Other Identifiers

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RTGX01

Identifier Type: -

Identifier Source: org_study_id