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

This study has been completed.
Information provided by (Responsible Party):
LivaNova Identifier:
First received: July 22, 2010
Last updated: December 2, 2015
Last verified: December 2015
Observational study is evaluating Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) thérapies as a function of ventricular pacing

Ventricular Tachycardia Ventricular Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Ventricular Pacing in Unselected ICD/CRT-D Patients

Resource links provided by NLM:

Further study details as provided by LivaNova:

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

Enrollment: 616
Study Start Date: November 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

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

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01169896

St Denis, France
Sponsors and Collaborators
Principal Investigator: Olivier Piot, MD CCN St Denis
  More Information

Responsible Party: LivaNova Identifier: NCT01169896     History of Changes
Other Study ID Numbers: RTGX01
Study First Received: July 22, 2010
Last Updated: December 2, 2015

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

Additional relevant MeSH terms:
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on September 21, 2017