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
  Purpose

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.


Condition
Ventricular Tachycardia
Ventricular Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Focus on the Impact of Ventricular Pacing in Unselected Implantable Cardiac Defibrillator (ICD) - Cardiac Resynchronization Therapy (CRT) Patients

Resource links provided by NLM:


Further study details as provided by Sorin Group:

Enrollment: 567
Study Start Date: November 2007
Estimated Study Completion Date: December 2011
Estimated 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

A total of 567 inclusions are required to demonstrate the main objective (global ICD/CRT-D implanted patients population).

Criteria

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.
  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
Sorin Group
Investigators
Principal Investigator: Olivier Piot, MD CCN St Denis
  More Information

No publications provided

Responsible Party: PIOT olivier, CCN Saint Denis
ClinicalTrials.gov Identifier: NCT01169896     History of Changes
Other Study ID Numbers: RTGX01- FIRST
Study First Received: July 22, 2010
Last Updated: July 23, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sorin Group:
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 August 19, 2014