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

Sponsor

CMC Ambroise Paré (Other)

Overall Status

Terminated

CT.gov ID

NCT03789487

Collaborator

(none)

Enrollment

Locations

Arm

18.7

Actual Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Cardiac Resynchronization Therapy	Device: Device programming of CRT pacemaker or defibrillator	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective Multicentric Study of Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients

Actual Study Start Date :

Feb 22, 2019

Actual Primary Completion Date :

Aug 21, 2020

Actual Study Completion Date :

Sep 14, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Hemodynamic response [During the optimization session]
Highest Systolic Blood Pressure (SBP) obtained by stimulation vector

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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