Heart Failure Clinical Trial
— HUMVEEOfficial title:
Heart Failure Study of Multi-site Pacing Effects on Ventriculoarterial Coupling
Verified date | September 2020 |
Source | National and Kapodistrian University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To perform a comparative study of multi-site left ventricular pacing and cardiac resynchronization therapy effects on ventriculoarterial coupling and energy efficiency of the failing heart
Status | Completed |
Enrollment | 80 |
Est. completion date | September 1, 2020 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Greece | First Department of Cardiology, Hippokration General Hospital | Athens | Attiki |
Lead Sponsor | Collaborator |
---|---|
National and Kapodistrian University of Athens |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement of ventriculoarterial coupling | Ventriculoarterial coupling value shifts closer to 1 | 6 months for each intervention (conventional CRT - MPP) | |
Primary | Improvement of energy efficiency | Energy efficiency improvement will be assessed by means of ventriculoarterial coupling value shifts closer to 0.7 | 6 months for each intervention (conventional CRT - MPP) | |
Secondary | Improvement in renal function | Creatinine clearance (Cockcroft-Gault formula) increases | 6 months for each intervention (conventional CRT - MPP) | |
Secondary | Improvement in percent maximal stroke work | Calculated through use of ventriculoarterial coupling | 6 months for each intervention (conventional CRT - MPP) |
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