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

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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure; Cardiac Resynchronization Therapy
• Intervention / Treatment: Device: Device programming of CRT pacemaker or defibrillator

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montmorency, France, 95160
    • GHEM Eaubonne
  • Poitiers, France, 86021
    • Chu de Poitiers
  • Ile De France
    • Neuilly-sur-Seine, Ile De France, France, 92200
      • CMC Ambroise Paré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic response	Highest Systolic Blood Pressure (SBP) obtained by stimulation vector	During the optimization session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Clinical response	Hospitalization for heart failure	at 6 months of follow up

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2019
• Primary Completion (Actual): August 21, 2020
• Study Completion (Actual): September 14, 2020

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (Actual): December 28, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiac Resynchronization Therapy; Non-responders; Pacing vector optimization; Atrioventricular delay optimization; Non invasive hemodynamic optimization
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2018/09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No