Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Dundee.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT01055210
First received: January 22, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

An evaluation of the role of resting and exercise cardiac output measurement, by the inert gas rebreathing method, in optimisation of patients with cardiac resynchronisation pacemakers.


Condition Intervention
Heart Failure
Cardiac Resynchronisation Pacemakers
Device: Optimisation of VV delay

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • 6 minute hall walk test [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Echocardiographic measures of desynchrony [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Optimisation of VV delay
    Programmed VV delay altered on device
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cardiac Resynchronization Device in situ for Heart Failure

Exclusion Criteria:

  • Unable to cope with mouthpiece
  • Estimated life expectancy < 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055210

Locations
United Kingdom
University of Dundee Not yet recruiting
Dundee, United Kingdom
Contact: Anna Maria Choy    01382 632108    a.choy@dundee.ac.uk   
Principal Investigator: Anna Maria Choy         
Sponsors and Collaborators
University of Dundee
Investigators
Principal Investigator: Anna- Maria Choy University of Dundee
  More Information

No publications provided

Responsible Party: Dr. Anna Maria Choy, University of Dundee
ClinicalTrials.gov Identifier: NCT01055210     History of Changes
Other Study ID Numbers: ELD002
Study First Received: January 22, 2010
Last Updated: January 22, 2010
Health Authority: United Kingdom: Research Ethics Service

Keywords provided by University of Dundee:
Heart Failure
Pacemakers

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014