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100 pt multicentre study 50 pts randomised to triventricular pacemaker, 50 to biventricular pacemaker Feasibility study with 6 month outcome data
100 patients with QRS duration (120-150ms LBBB) for device insertion as per ESC guidelines 2013 will be recruited to the study from 10 centres. Patients will undergo the pre-operative work up that is typical of their institution (for example at the GSTT site this will include cardiac MRI, cardiopulmonary exercise testing (CPET), 6 minute walk test , bloods including Nt pro BNP, Minnesota living with heart failure questionnaire (MLWHFQ), 2D/3D echocardiogram and the collection of demographic data.)
Patients will then be randomised in a 1:1 fashion to receive either the Triventricular device or the conventional biventricular device.
Participants will then be followed up as per the implanting institution's typical follow up. (for example at GSTT this will include 6 week atrio-ventricular and ventricular-ventricular optimisation (if patients have a device that does not autooptimise) and review by a clinician as well as a 6 month follow up at which point the CPET, 6 minute walk test , MLWHFQ, bloods including Nt pro BNP, 2D/3D echocardiogram and the collection of demographic data will be repeated.)
Regardless of the institution's own follow up, a 6 week (4-8 week) and 6 month (5-9month) follow up appointment will form part of the study protocol. The 6 week check will be take the form of a standard clinical pacing check with physician input if it is deemed necessary as per the host institution's usual standard of care/ (usually one would imagine if a problem of therapy delivery is noted)
The 6 month follow up will allow for patient and device follow up. This will require 2D echocardiography, 6 min walk test, MLWHFQ and NtproBNP measurement. Where possible institutions will be encouraged to perform CPET and 3D echocardiography pre implant and at 6 months.
For determining the " response rate", a positive response will be defined as an absolute reduction of LVESV by 15%. In order to determine the magnitude of response then the change in LVESV will be assessed as a continuous variable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triventricular pacing | Experimental | 2 Left ventricular leads and one right ventricular lead |
|
| Biventricular leads | Active Comparator | 1 left ventricular lead and one right ventricular lead |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronisation Therapy | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of achieving and maintaining triventricular pacing at 6 months | Percentage of patients having triventricular pacing at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who successfully reverse remodel as per echo (success being defined as a reduction in end systolic volume of > 15% | outcome | 6 months |
| Proportionate effect of intervention and comparator with regard to reverse remodelling (comparison of % reduction in left ventricular end systolic volume ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simon Claridge, MBBS | Contact | 02071887188 | simon.claridge@kcl.ac.uk | |
| Aldo Rinaldi, MD | Contact | aldo.rinaldi@gstt.nhs.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's and St Thomas Hospital Trust | Recruiting | London | Se1 7EH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35079787 | Derived | Gould J, Claridge S, Jackson T, Sieniewicz BJ, Sidhu BS, Porter B, Elliott MK, Mehta V, Niederer S, Chadwick H, Kamdar R, Adhya S, Patel N, Hamid S, Rogers D, Nicolson W, Chan CF, Whinnett Z, Murgatroyd F, Lambiase PD, Rinaldi CA. Standard care vs. TRIVEntricular pacing in Heart Failure (STRIVE HF): a prospective multicentre randomized controlled trial of triventricular pacing vs. conventional biventricular pacing in patients with heart failure and intermediate QRS left bundle branch block. Europace. 2022 May 3;24(5):796-806. doi: 10.1093/europace/euab267. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 2, 2021 | |
| Reset | Feb 19, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 2, 2021 | Feb 19, 2021 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| D047548 | Defibrillators |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D004566 | Electrodes |
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outcome |
| 6 months |
| Proportion of patients who successfully reverse remodel as per echo (success being defined as a reduction in end systolic volume of > 15% with prespecified subgroups (AF and aetiology) | 6 months | 6 months |
| Proportionate effect of intervention and comparator with regard to reverse remodelling (comparison of % reduction in left ventricular end systolic volume ) (AF and aetiology) | outcome | 6 months |
| Mean change in Nt proBNP in patients with triventricular devices compared with biventricular devices (pg/ml) | outcome | 6 months |
| Comparison of effect of biventricular and triventricular pacing on scores in the Minnesota Living with Heart Failure Questionnaire | outcome | 6 months |
| Comparison of effect of biventricular and triventricular pacing on change in 6 minute walk test (metres) | outcome | 6 months |
| Percentage change in Nt proBNP in patients with triventricular devices compared with biventricular devices | outcome | 6 months |
| Comparison of percentage of shocks delivered in triventricular arm vs biventricular arm | outcome | 6 months |
| D055615 |
| Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |