Status:
UNKNOWN
Effects of Preferential Left Ventricular Pacing on Ventriculoarterial Coupling and Clinical Course of Heart Failure
Lead Sponsor:
National and Kapodistrian University of Athens
Conditions:
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Randomized trial of adult patients to study the effects of preferential left ventricular pacing on ventriculoarterial coupling of both systemic and pulmonary circulation, indices of systolic and diast...
Detailed Description
Study hypothesis is that preferential left ventricular (LV) pacing, delivered by means of the AdaptivCRT® algorithm and in conjunction with automated V-V delay adjustments, will lead to improvements o...
Eligibility Criteria
Inclusion
- Age 18-80 years old Provided informed consent Any cardiomyopathy type, diagnosed at least 6 months prior (to exclude recent myocarditis cases that may remit and confound outcomes) On optimal medical therapy for at least 3 months, An existing I/IIa indication for a CRT-D device Both new CRT-D implantation and an upgrade from an existing ICD or pacemaker with no prior left ventricular lead placement.
Exclusion
- Have an existing Class I recalled lead,
- Are anticipated to need heart transplantation within the next 9 months,
- Have undergone cardiac transplantation less than 40 days prior to enrolment,
- Have had a cerebrovascular accident or transient ischemic attack within 3 months of enrollment,
- Have had a recent myocardial infarction less than 40 days prior to enrollment, or unstable angina or cardiac revascularization less than 3 months prior to enrolment,
- Have documented moderate to severe/severe mitral/aortic/tricuspid/pulmonary insufficiency (noninvasive VAC calculation impossible),
- Exhibit a daily burden of premature ventricular complexes (PVCs) of either ≥10% of total QRSs or ≥10,000 on ambulatory ECG recording21, 22 (to exclude PVC-related, potentially reversible cardiomyopathy),
- Are currently participating in a clinical investigation that includes an active treatment arm,
- Have diagnosed pulmonary hypertension other than class II (left heart-related),
- Have known stage IV-V renal dysfunction (clearance estimated by the Cockcroft-Gault equation),
- Have permanent atrial fibrillation,
- Have complete atrioventricular block,
- Have a prolonged (\>200msec) PQ interval on surface ECG (thus invalidating the option for preferential LV pacing),
- Are pregnant or planning to become pregnant during the duration of the study (in case of unplanned pregnancy the patient will have to be excluded from the study),
- Have an expected life expectancy of \<12 months, or
- Undergo major adaptations to their pharmacological regimens during follow-up (e.g. initiation of neprilysin inhibitors).
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04420065
Start Date
September 1 2020
End Date
December 31 2024
Last Update
June 9 2020
Active Locations (1)
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1
First University Department of Cardiology, Hippokrateion General Hospital
Athens, Attica, Greece, 11527