Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients (OPTIREG)
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|ClinicalTrials.gov Identifier: NCT03789487|
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : April 24, 2019
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality. However, one-third of patients are non-responders. Among factors associated with non-response, suboptimal electrical settings of the device, i.e. inadequate pacing vector selection and atrioventricular (AV) delay, is an important cause.
The aim of the study is to investigate whether the optimization of CRT settings (pacing vector and AV delay) results in improved clinical and echocardiographic outcomes in a non-responder CRT population after 6 months of therapy.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Cardiac Resynchronization Therapy||Device: Device programming of CRT pacemaker or defibrillator||Not Applicable|
This study is non-randomized, prospective, interventional, multicentric study. Patients who have been implanted with a CRT device between 6 and 18 months prior to inclusion and are considered non-responders are eligible for this study. CRT non-response can be clinical (lack of functional improvement or hospitalization for heart failure) and/or echocardiographic (insufficient improvement of LVEF and/or reduction of LVESV). Among exclusion criteria, permanent atrial fibrillation is of note.
Recruited patients will be submitted to an optimization procedure of their CRT device settings. This will be performed with a non-invasive method using the Finapress NOVA device, which records blood pressure with a digital cuff. The peak of blood pressure will correspond to the optimal device settings. The first step will be to chose the best pacing vector. The second step will be to chose the best AV delay. The best setting, i.e. associated with the highest blood pressure, will be programmed at the end of the optimization protocol.
The patients will be followed at 6 months with clinical evaluation and echocardiography to assess the conversion rate of non-responders to responders.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Multicentric Study of Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients|
|Actual Study Start Date :||February 22, 2019|
|Estimated Primary Completion Date :||August 21, 2020|
|Estimated Study Completion Date :||March 21, 2021|
Experimental: Non-responders to CRT
Non-responders to CRT who will undergo an electrical optimization of the settings of their device
Device: Device programming of CRT pacemaker or defibrillator
Stimulation vector optimization then AV delay optimization in order to obtain the highest systolic blood pressure (SBP) by using the Finapress® NOVA noninvasive device
- Hemodynamic response [ Time Frame: During the optimization session ]Highest Systolic Blood Pressure (SBP) obtained by stimulation vector
- echocardiographic response [ Time Frame: at 6 months of follow-up ]Left Ventricular Ejection Fraction (LVEF), Left Ventricular end-diastolic Volume (LVEDV), Left Ventricular End-Systolic Volume (LVESV)
- Clinical response [ Time Frame: at 6 months of follow up ]Hospitalization for heart failure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789487
|Contact: MOUBARAK Ghassan, MD||(+33) 1 46 39 50 firstname.lastname@example.org|
|CMC Ambroise Paré||Recruiting|
|Neuilly-sur-Seine, Ile De France, France, 92200|
|Contact: Ghassan A Moubarak, MD +33146415079|
|Principal Investigator: Ghassan Moubarak, MD|
|Sub-Investigator: Verginie Ferchaud, MD|