Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients (OPTIREG)

CMC Ambroise Paré

Status

Terminated

Conditions

Cardiac Resynchronization Therapy

Heart Failure

Treatments

Device: Device programming of CRT pacemaker or defibrillator

Study type

Interventional

Funder types

Other

Identifiers

NCT03789487

2018/09

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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