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Focus on the Impact of Ventricular Pacing in Unselected Implantable Cardioverter Defibrillator-Cardiac Resynchronization Therapy Defibrillator (ICD-CRTD) Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Sorin Group.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT01169896
First received: July 22, 2010
Last updated: July 23, 2010
Last verified: July 2010
History of Changes

July 22, 2010
July 23, 2010
November 2007
December 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01169896 on ClinicalTrials.gov Archive Site
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Focus on the Impact of Ventricular Pacing in Unselected Implantable Cardioverter Defibrillator-Cardiac Resynchronization Therapy Defibrillator (ICD-CRTD) Patients
Focus on the Impact of Ventricular Pacing in Unselected Implantable Cardiac Defibrillator (ICD) - Cardiac Resynchronization Therapy (CRT) Patients

The primary objective of this observational study is to show that ICD VR and DR patients presenting more than 50% cumulative right ventricular pacing percentage present significantly more therapies for Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF)episodes compared to ICD patients presenting less than 50% cumulative ventricular pacing percentage during two years follow-up.

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 and will address the following:

Impact of ventricular pacing on patients outcome: impact of ventricular pacing on the incidence of VT/VF episodes for each models, incidence of atrial arrhythmia for each models, evolution of the cardiopathy (New York Heart Association NYHA Class, Left Ventricular Ejection Fraction LVEF), morbidity.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

A total of 567 inclusions are required to demonstrate the main objective (global ICD/CRT-D implanted patients population).
  • Ventricular Tachycardia
  • Ventricular Fibrillation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
567
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient implanted (primo implantation or replacement) with an ICD* from SORIN Group: Model 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.
  • Patient has signed the informed consent for the use of her/his data (if applicable).

Exclusion Criteria:

  • Presence of a contra-indication to the ICD therapy.
  • Life expectancy less than 12 months.
  • Inability or refusal to provide informed consent to the data treatment if applicable.
  • Not available for routine follow-up visits.
  • Minors (<18) and pregnant women.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01169896
RTGX01- FIRST
No
PIOT olivier, CCN Saint Denis
Sorin Group
Not Provided
Principal Investigator: Olivier Piot, MD CCN St Denis
Sorin Group
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP