Cardiac Resynchronization Therapy, Heart Failure
Conditions
Keywords
Cardiac Resynchronization Therapy, Non-responders, Pacing vector optimization, Atrioventricular delay optimization, Non invasive hemodynamic optimization, Heart Failure
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDevice 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
Sponsors
CMC Ambroise Paré
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient older than 18 * Patient implanted with a CRT (CRT-P or CRT-D) more than 6 months but less than 18 months before inclusion * Non-responder patients: Clinical criteria (Packer classification): Lack of improvement of NYHA functional class And/or hospitalization for heart failure Echocardiographic criteria: Lack of improvement of LVEF \> 5points And/or reduction of LVESV \< 15% * Patient who had signed an informed consent and is willing to comply with study requirements * Patient covered by French national healthcare insurance
Exclusion criteria
* Permanent/persistant atrial fibrillation/ supra-ventricular tachycardia * Scheduled hospitalization for major cardiac intervention or cardiac surgery in the 6 coming months * Life-expectancy of less than 6 months * Pregnant or breastfeeding women * Adults under legal protection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic response | During the optimization session | Highest Systolic Blood Pressure (SBP) obtained by stimulation vector |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| echocardiographic response | 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 | at 6 months of follow up | Hospitalization for heart failure |
Countries
France
Outcome results
None listed