NCT00221780

Brief Summary

Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site. We study in a random order 11 different left ventricular pacing sites and compare their hemodynamics using pressure-volume catheters. The consequences on the surface ECG are also assessed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Nov 2003

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 29, 2007

Status Verified

June 1, 2007

First QC Date

September 13, 2005

Last Update Submit

June 28, 2007

Conditions

Heart FailureCardiomyopathy, DilatedCoronary Disease

Keywords

Heart failureCardiomyopathy, dilatedCoronary diseaseCardiac Pacing, ArtificialHemodynamicsRandomized Controlled TrialsSingle-Blind Study

Outcome Measures

Primary Outcomes (1)

  • Variation in left ventricular dp/dt max

Secondary Outcomes (3)

  • pressures and volumes of the left ventricle

  • stroke work

  • surface ECG repolarisation

Interventions

left ventricular pacingDEVICE

Eligibility Criteria

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

You may qualify if:

  • Heart failure referred for cardiac resynchronization therapy
  • NYHA Class III or IV
  • Informed consent form signed

You may not qualify if:

  • Hypertension not controlled by treatment
  • Coronary ischemia not controlled by treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cardiologique du Haut Lévêque, Rythmology department, Pr CLEMENTY, 3rd Floor

Pessac, 33604, France

RECRUITING

MeSH Terms

Conditions

Heart FailureCardiomyopathy, DilatedCoronary Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCardiomegalyCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMyocardial IschemiaVascular Diseases

Study Officials

  • Pierre Jaïs, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Paul Perez, Dr

    University Hospital, Bordeaux

    STUDY CHAIR

Central Study Contacts

Pierre Jaïs, Dr

CONTACT

33 (0) 5 57 65 64 71pierre.jais@chu-bordeaux.fr

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

November 1, 2003

Study Completion

December 1, 2007

Last Updated

June 29, 2007

Record last verified: 2007-06

Locations

FR(1)