Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients

Heart Failure Clinical Trial

— OPTIREG  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03789487
• Other study ID #: 2018/09
• Status: Terminated
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: September 14, 2020

Study information

• Verified date: January 2021
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: September 14, 2020
• Est. primary completion date: August 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
France	GHEM Eaubonne	Montmorency
France	CMC Ambroise Paré	Neuilly-sur-Seine	Ile De France
France	CHU de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic response	Highest Systolic Blood Pressure (SBP) obtained by stimulation vector	During the optimization session
Secondary	echocardiographic response	Left Ventricular Ejection Fraction (LVEF), Left Ventricular end-diastolic Volume (LVEDV), Left Ventricular End-Systolic Volume (LVESV)	at 6 months of follow-up
Secondary	Clinical response	Hospitalization for heart failure	at 6 months of follow up