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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03189368 |
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Date of registration:
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12/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Heart Failure Study of Multi-site Pacing Effects on Ventriculoarterial Coupling
HUMVEE |
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Scientific title:
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Heart Failure Study of Multi-site Pacing Effects on Ventriculoarterial Coupling |
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Date of first enrolment:
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September 18, 2017 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03189368 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Greece
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult (>18 years of age), consenting patients
- Any cardiomyopathy type and
- An existing I/IIa indication for a CRT-D device
Exclusion Criteria:
- Those with a class IIb CRT indication
- Those where thresholds of <3.5V@0.5msec cannot be achieved in at least two dipoles of
the left pacing electrode
- Those where no dipole with a distance between poles of 30mm can be detected
- Those with >2/4 (moderate to severe - severe) mitral/aortic insufficiency, rendering
noninvasive VAC calculation unreliable.
- Finally, contraindication to receiving intravenous paramagnetic contrast (gadolinium)
will also constitute grounds for exclusion.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Heart Failure
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Intervention(s)
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Device: Activation of multi-site pacing capability on CRT devices
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Primary Outcome(s)
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Improvement of energy efficiency
[Time Frame: 6 months for each intervention (conventional CRT - MPP)]
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Improvement of ventriculoarterial coupling
[Time Frame: 6 months for each intervention (conventional CRT - MPP)]
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Secondary Outcome(s)
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Improvement in renal function
[Time Frame: 6 months for each intervention (conventional CRT - MPP)]
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Improvement in percent maximal stroke work
[Time Frame: 6 months for each intervention (conventional CRT - MPP)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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