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

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ClinicalTrials.gov Identifier: NCT01169896
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
LivaNova

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

Condition or disease
Ventricular Tachycardia Ventricular Fibrillation

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.

Study Type : Observational
Actual Enrollment : 616 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Ventricular Pacing in Unselected ICD/CRT-D Patients
Study Start Date : November 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011





Primary Outcome Measures :
  1. VT/VF episodes according to ventricular pacing (> and <50%) [ Time Frame: 2 years ]
    Device-based data



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
unselected ICD/CRT-D implanted patients
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169896


Locations
France
CCN
St Denis, France
Sponsors and Collaborators
LivaNova
Investigators
Principal Investigator: Olivier Piot, MD CCN St Denis

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT01169896     History of Changes
Other Study ID Numbers: RTGX01
First Posted: July 26, 2010    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by LivaNova:
Impact of ventricular pacing on the incidence of VT/VF episodes for each models

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes