Clinical trial NCT03789487: Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients
Official title: Prospective Multicentric Study of Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Cardiac Resynchronization Therapy
Keywords: Cardiac Resynchronization Therapy
Non-responders
Pacing vector optimization
Atrioventricular delay optimization
Non invasive hemodynamic optimization
Heart Failure
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemodynamic response
timeFrame: During the optimization session
Secondary outcomes:
measure: echocardiographic response
timeFrame: at 6 months of follow-up
measure: Clinical response
timeFrame: at 6 months of follow up
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: CMC Ambroise Paré
state: Ile De France
city: Montmorency
country: France
facility: GHEM Eaubonne
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References: