Heart FailurePhase 4TRIVENTNCT00941850
A Study of Triple-site Ventricular Pacing in Patients Who Have Not Responded to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy
A Phase 4 study testing Upgrade to triple ventricular site CRT in people with Heart Failure, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
Patients are randomised to receive ongoing optimised device and medical therapy or triple ventricular site resynchronisation. The hypothesis states that patients receiving triple-site resynchronization will exhibit a better response. 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?
- Upgrade to triple ventricular site CRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2009to Nov 2012
- Phase
- Phase 4
- 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
- Implanted with a CRT device > 6 months previously according to current and conventional CRT indications
- Device optimization > 1 months previously
- Aged 18yrs or older
- Able to attend outpatient follow up
Who cannot join
- Recent MI (<2 months)
- Women who are pregnant or planning pregnancy
- Severe co morbid illness (where patients are not expected to survive duration of follow up period or where repeated outpatient visits may not be in best interest of patients)
- Upgrade procedure is contraindicated for safety reasons.
- Class IV inotropic agents
- Patient unwilling to comply with required follow-up protocol including randomization scheme
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leicester HNS trust
Leicester, England, LE3 9QP
About this study
Official title: TRIple-site VENTricular Pacing in Non-responders to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy
Patients are randomised to receive ongoing optimised device and medical therapy or triple ventricular site resynchronisation. The hypothesis states that patients receiving triple-site resynchronization will exhibit a better response.
- Conditions
- Heart Failure
- Being tested
- Upgrade to triple ventricular site CRT
- Keywords
- Cardiac resynchronizton therapy, CRT, Heart failure, Dyssynchrony, Echocardiography, Pacemakers, Nonresponders
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upgrade to triple ventricular site CRTProcedure or surgery
Patients in this arm will continue to receive CRT via the original unit, but some will have a change in the mode of delivery of therapy (by placing a second pacing lead to reach a different part of the left ventricle from the part originally paced).
| Study group | Role | What they receive |
|---|---|---|
| Triple site CRT | Experimental | These patients will continue to receive CRT via existing device but will have a change in the mode of delivery of therapy (by placing a second pacing lead to reach a different part of the left ventricle from the part originally paced Receives: Procedure: Upgrade to triple ventricular site CRT |
| Optimised medical and device therapy | No intervention | These patients will receive optimised medical and device therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of responders in each group. o Clinical response will be defined according to the Packer score o Echocardiographic response will be defined as a 10% relative reduction in left ventricular end systolic volume at six months
Measured: 6 months
Secondary outcomes (3)
NYHA class
Measured: 3 and 6 months
ECHO parameters (LVEDV/ESV, LVEF, MR severity, dyssynchrony indices: time to peak velocity/strain/deformation/time to minimal volume)
Measured: 3 and 6 months
MVO2 max
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2012
- Study completionNov 2012
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GAndre Ng, MB ChB, PhD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941850
- Sponsor's protocol ID
- UHL10707
- Acronym
- TRIVENT
- Status last verified
- Dec 2015
- First submitted
- 16 Jul 2009
- Last updated
- 8 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRIple-site VENTricular Pacing in Non-responders to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT00941850
- Acronym / sponsor ID
- TRIVENT / UHL10707
- Conditions
- Heart Failure
- Keywords
- Cardiac resynchronizton therapy, CRT, Heart failure, Dyssynchrony, Echocardiography, Pacemakers, Nonresponders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 20 Jul 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.
Patients are randomised to receive ongoing optimised device and medical therapy or triple ventricular site resynchronisation. The hypothesis states that patients receiving triple-site resynchronization will exhibit a better response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple site CRT | Experimental | Procedure: Upgrade to triple ventricular site CRTThese patients will continue to receive CRT via existing device but will have a change in the mode of delivery of therapy (by placing a second pacing lead to reach a different part of the left ventricle from the part originally paced |
| Optimised medical and device therapy | No intervention | –These patients will receive optimised medical and device therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Implanted with a CRT device > 6 months previously according to current and conventional CRT indications
- Device optimization > 1 months previously
- Aged 18yrs or older
- Able to attend outpatient follow up
Key exclusion criteria (6 listed)
- Recent MI (<2 months)
- Women who are pregnant or planning pregnancy
- Severe co morbid illness (where patients are not expected to survive duration of follow up period or where repeated outpatient visits may not be in best interest of patients)
- Upgrade procedure is contraindicated for safety reasons.
- Class IV inotropic agents
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 |
|---|---|---|
| Upgrade to triple ventricular site CRTPatients in this arm will continue to receive CRT via the original unit, but some will have a change in the mode of delivery of therapy (by placing a second pacing lead to reach a different part of the left ventricle from the part originally paced). | Procedure or surgery | Triple site CRT |
Primary outcome
Proportion of responders in each group. o Clinical response will be defined according to the Packer score o Echocardiographic response will be defined as a 10% relative reduction in left ventricular end systolic volume at six months
Time frame: 6 months
3 secondary outcomes
NYHA class
Time frame: 3 and 6 months
ECHO parameters (LVEDV/ESV, LVEF, MR severity, dyssynchrony indices: time to peak velocity/strain/deformation/time to minimal volume)
Time frame: 3 and 6 months
MVO2 max
Time frame: 6 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 8 Dec 2015.
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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.
GAndre Ng, MB ChB, PhD principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Upgrade to triple ventricular site CRT in people with Heart Failure, run by University Hospitals, Leicester 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 6 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 8 Dec 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of responders in each group. o Clinical response will be defined according to the Packer score o Echocardiographic response will be defined as a 10% relative reduction in left ventricular end systolic volume at six months (time frame: 6 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 8 Dec 2015.