Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LivaNova
ClinicalTrials.gov Identifier:
NCT01169896
First received: July 22, 2010
Last updated: December 2, 2015
Last verified: December 2015
  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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: July 22, 2010
Last Updated: December 2, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on December 06, 2016