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

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Renewal TR2
Sponsored by
Guidant Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congestive Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHG Albi
  • CHU Michalon
  • CH La Croix Rousse
  • Hôpital Louis Pradel
  • Nouvelle Clinique Nantaise
  • CHU Nîmes
  • CHG Perigueux
  • Hôpital Pontchaillou
  • Centre Cardiologique du Nord
  • Clinique Pasteur

Outcomes

Primary Outcome Measures

Occurrence of ventricular arrhythmias
Occurrence of supraventricular arrhythmias

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
December 12, 2007
Sponsor
Guidant Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00180531
Brief Title
Monitoring of Arrhythmias and HRV in Patients With Heart Failure Treated With the CRT Pacemaker Renewal TR2
Official Title
Monitoring of Arrhythmias and Heart Rate Variability in Patients With Congestive Heart Failure Treated With the Cardiac Resynchronisation Pacemaker Renewal TR2
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Guidant Corporation

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Renewal TR2
Primary Outcome Measure Information:
Title
Occurrence of ventricular arrhythmias
Title
Occurrence of supraventricular arrhythmias

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P. CHEVALIER, MD
Organizational Affiliation
Hôpital Louis Pradel, Lyon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
S Boveda, MD
Organizational Affiliation
Clinique Pasteur
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHG Albi
City
Albi
ZIP/Postal Code
81013
Country
France
Facility Name
CHU Michalon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CH La Croix Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Hôpital Louis Pradel
City
Lyon
ZIP/Postal Code
69394
Country
France
Facility Name
Nouvelle Clinique Nantaise
City
Nantes
ZIP/Postal Code
44227
Country
France
Facility Name
CHU Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
CHG Perigueux
City
Perigueux
ZIP/Postal Code
24019
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Cardiologique du Nord
City
Saint Denis
ZIP/Postal Code
93207
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19264750
Citation
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.
Results Reference
derived

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

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