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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01169896
First Posted: July 26, 2010
Last Update Posted: December 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LivaNova
  Purpose
Observational study is evaluating Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) thérapies as a function of ventricular pacing

Condition
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.
  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT01169896     History of Changes
Other Study ID Numbers: RTGX01
First Submitted: July 22, 2010
First Posted: July 26, 2010
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