Heart FailureCHOICENCT00875732
Choosing the Right Pacing Mode in Heart Failure - The CHOICE Trial
A study testing Bi Ventricular Pacing and Right Ventricular Pacing in people with Heart Failure, run by University of Dundee at 1 site in United Kingdom.
Trial summary
The aim of the study is to see if biventricular pacemakers offer any advantage over conventional pacemakers in patients with heart failure who require pacemakers. The endpoints will be the 6 minute walking distance along with markers of cardiovascular function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Bi Ventricular Pacing and Right Ventricular Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left ventricular systolic dysfunction.
- Atrio-ventricular node disease.
- Anticipated to be more than 40% paced, (including patients in permanent atrial fibrillation).
- Ability to walk independently (walking aid permitted).
Who cannot join
- Patients meeting criteria for CRT by current guidelines will be excluded.
- Life expectancy less than12 months.
- Inability to walk independently.
- Patients not likely to be compliant with follow-up.
- Bradyarrhythmia due with sino-atrial disease only.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ninewells Hospital & Medical School
Dundee, UK, DD1 9SY
About this study
Official title: CHOosing the rIght paCing Mode in Heart failurE : Should Heart Failure Patients With Bradycardia Receive Biventricular Pacemakers Rather Than Conventional Pacemakers?
The aim of the study is to see if biventricular pacemakers offer any advantage over conventional pacemakers in patients with heart failure who require pacemakers. The endpoints will be the 6 minute walking distance along with markers of cardiovascular function.
The investigators' hypothesis is that biventricular pacing is preferable to conventional pacing in these heart failure patients.
- Conditions
- Heart Failure
- Being tested
- Bi Ventricular Pacing, Right Ventricular Pacing
- Keywords
- Resynchronization, Device, Bradycardia, atrioventricular block, Cardiac Resynchronization
- Medical subject headings
- Heart Failure, Bradycardia, Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi Ventricular PacingDevice
Right Ventricular PacingDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Biventricular Pacing Receives: Device: Bi Ventricular Pacing |
| 2 | Active comparator | Right Ventricular Pacing Receives: Device: Right Ventricular Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute hall walk test
Measured: Baseline, 3, 6, 9 and 12 months
Secondary outcomes (2)
Endothelial Function
Measured: Baseline, 3, 6, 9 and 12 months
Cardiac Output
Measured: Baseline, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- Chest, Heart and Stroke Association Scotland, Abbott Medical Devices
- Responsible party
- Principal investigator, AChoy, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875732
- Sponsor's protocol ID
- ELD001
- Acronym
- CHOICE
- Status last verified
- Jul 2017
- First submitted
- 31 Mar 2009
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHOosing the rIght paCing Mode in Heart failurE : Should Heart Failure Patients With Bradycardia Receive Biventricular Pacemakers Rather Than Conventional Pacemakers?
- ClinicalTrials.gov ID
- NCT00875732
- Acronym / sponsor ID
- CHOICE / ELD001
- Conditions
- Heart Failure
- Keywords
- Resynchronization, Device, Bradycardia, atrioventricular block, Cardiac Resynchronization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- Chest, Heart and Stroke Association Scotland, Abbott Medical Devices
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to see if biventricular pacemakers offer any advantage over conventional pacemakers in patients with heart failure who require pacemakers. The endpoints will be the 6 minute walking distance along with markers of cardiovascular function.
The investigators' hypothesis is that biventricular pacing is preferable to conventional pacing in these heart failure patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Bi Ventricular PacingBiventricular Pacing |
| 2 | Active comparator | Device: Right Ventricular PacingRight Ventricular Pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Left ventricular systolic dysfunction.
- Atrio-ventricular node disease.
- Anticipated to be more than 40% paced, (including patients in permanent atrial fibrillation).
- Ability to walk independently (walking aid permitted).
Key exclusion criteria (5 listed)
- Patients meeting criteria for CRT by current guidelines will be excluded.
- Life expectancy less than12 months.
- Inability to walk independently.
- Patients not likely to be compliant with follow-up.
- Bradyarrhythmia due with sino-atrial disease only.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bi Ventricular Pacing | Device | 1 |
| Right Ventricular Pacing | Device | 2 |
Primary outcome
6 minute hall walk test
Time frame: Baseline, 3, 6, 9 and 12 months
2 secondary outcomes
Endothelial Function
Time frame: Baseline, 3, 6, 9 and 12 months
Cardiac Output
Time frame: Baseline, 3, 6, 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi Ventricular Pacing and Right Ventricular Pacing in people with Heart Failure, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute hall walk test (time frame: Baseline, 3, 6, 9 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.