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Monitoring of Arrhythmias and HRV in Patients With Heart Failure Treated With the CRT Pacemaker Renewal TR2

NCT ID: NCT00180531

Last Updated: 2007-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2007-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Renewal TR2

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Moderate or severe chronic heart failure, defined by the presence of NYHA class III or IV symptoms, Intra/interventricular synchronization disorder evaluated by echocardiography and/or Doppler Tissue Imaging (DTI, Yu's method22), Ejection fraction (EF) ≤ 40 %, If previous history of myocardial infarction, MI must be \> 60 days from the date of inclusion, Estimated life expectancy \> 6 months in the case of concomitant disease, Age ≥ 18 years, Optimal drug treatment of chronic heart failure (according to SFC\* recommendations).

Exclusion Criteria

* Conventional indication for treatment by implantable defibrillator upon inclusion, Cardiac transplant envisaged within 6 months, Unexplained syncope, MI \< 60 days before inclusion, Non compliance to drug treatment for chronic heart failure, Any coronary pathology which may be treated by revascularisation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guidant Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Guidant France

Principal Investigators

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P. CHEVALIER, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Louis Pradel, Lyon

S Boveda, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Pasteur

Locations

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CHG Albi

Albi, , France

Site Status

CHU Michalon

Grenoble, , France

Site Status

CH La Croix Rousse

Lyon, , France

Site Status

Hôpital Louis Pradel

Lyon, , France

Site Status

Nouvelle Clinique Nantaise

Nantes, , France

Site Status

CHU Nîmes

Nîmes, , France

Site Status

CHG Perigueux

Périgueux, , France

Site Status

Hôpital Pontchaillou

Rennes, , France

Site Status

Centre Cardiologique du Nord

Saint-Denis, , France

Site Status

Clinique Pasteur

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 19264750 (View on PubMed)

Other Identifiers

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Mona Lisa v. 1.1 3/12/03

Identifier Type: -

Identifier Source: org_study_id