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

• Sponsor: University of Dundee (Other)
• Overall Status: Completed
• CT.gov ID: NCT01055210
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Duration (Months): 42
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Heart Failure; Cardiac Resynchronisation Pacemakers	Device: Optimisation of VV delay	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Outcome Measures

Primary Outcome Measures

1. 6 minute hall walk test [4 months]

Secondary Outcome Measures

1. Echocardiographic measures of desynchrony [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Dundee	Dundee		United Kingdom

Sponsors and Collaborators

• University of Dundee

Investigators

• Principal Investigator: Anna- Maria Choy, University of Dundee

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Dundee
• ClinicalTrials.gov Identifier: NCT01055210
• Other Study ID Numbers: ELD002
• First Posted: Jan 25, 2010
• Last Update Posted: Dec 3, 2018
• Last Verified: Jan 1, 2010

• Keywords provided by University of Dundee: Heart Failure; Pacemakers
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Dec 3, 2018