NCT00187265

Brief Summary

The purpose of this study is to evaluate the feasibility of permanent biventricular pacing using three ventricular leads, and its efficacy in terms of inter and intra-ventricular resynchronization, in patients with congestive heart failure and a non-functional atrium (chronic AF).

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

1 active site

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

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

First QC Date

September 13, 2005

Last Update Submit

February 1, 2019

Conditions

Heart FailureVentricular Dyssynchrony

Outcome Measures

Primary Outcomes (1)

  • Z-ratio

Interventions

Cardiac Resynchronization TherapyDEVICE

Eligibility Criteria

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

You may qualify if:

  • NYHA class III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure for 1 month.
  • The medical treatment must include a 40 mg/day minimum dose of furosemide (or equivalent);
  • Permanent atrial fibrillation (AF);
  • Left ventricular ejection fraction (LVEF) ≤ 35%;
  • Indication for a pacemaker implantation for a permanent and symptomatic bradycardia, or already implanted pacemaker under the condition that leads positioning corresponds to the criteria described in the protocol;
  • Aortic pre-ejection delay at least equal to 140 ms.

You may not qualify if:

  • Indication for a cardiac defibrillator;
  • Having presented a myocardial infarct within the previous 3 months;
  • Having undergone cardiac surgery or coronary revascularization procedure within the previous 3 months, or being scheduled for such procedures;
  • Presenting chronic pulmonary insufficiency;
  • Patients whose congestive heart failure requires the use of an intravenous inotropic support;
  • Presenting a dysthyreosis;
  • Having a life expectancy of less than one year, for other reasons than the congestive heart failure;
  • Unable to be followed-up in the scope of the study for geographical reasons;
  • Having refused to give their consent;
  • Minors (age \< 18 years) and pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology - CHU Pontchaillou

Rennes, 35011, France

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Jean-Claude Daubert

    CHU Pontchaillou Rennes France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

April 1, 2003

Study Completion

October 1, 2005

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

FR(1)