NCT00180531

Brief Summary

The objective of this study is to evaluate the prevalence of sustained ventricular and supraventricular rhythm disorders in patients implanted with a CONTAK RENEWAL TR2 ventricular resynchronization therapy (CRT) device

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2004

Typical duration for phase_4

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

December 13, 2007

Status Verified

December 1, 2007

First QC Date

September 14, 2005

Last Update Submit

December 12, 2007

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Occurrence of ventricular arrhythmias

  • Occurrence of supraventricular arrhythmias

Interventions

Renewal TR2DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHG Albi

Albi, 81013, France

Location

CHU Michalon

Grenoble, 38043, France

Location

CH La Croix Rousse

Lyon, 69317, France

Location

Hôpital Louis Pradel

Lyon, 69394, France

Location

Nouvelle Clinique Nantaise

Nantes, 44227, France

Location

CHU Nîmes

Nîmes, 30029, France

Location

CHG Perigueux

Périgueux, 24019, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Centre Cardiologique du Nord

Saint-Denis, 93207, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Related Publications (1)

  • Boveda S, Marijon E, Jacob S, Defaye P, Winter JB, Bulava A, Gras D, Albenque JP, Combes N, Pavin D, Delarche N, Teubl A, Lambiez M, Chevalier P; Mona Lisa Study Group. Incidence and prognostic significance of sustained ventricular tachycardias in heart failure patients implanted with biventricular pacemakers without a back-up defibrillator: results from the prospective, multicentre, Mona Lisa cohort study. Eur Heart J. 2009 May;30(10):1237-44. doi: 10.1093/eurheartj/ehp071. Epub 2009 Mar 4.

    PMID: 19264750DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • P. CHEVALIER, MD

    Hôpital Louis Pradel, Lyon

    PRINCIPAL INVESTIGATOR

  • S Boveda, MD

    Clinique Pasteur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

February 1, 2004

Study Completion

June 1, 2007

Last Updated

December 13, 2007

Record last verified: 2007-12

Locations

FR(10)