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

• ClinicalTrials.gov Identifier: NCT03789487
• Recruitment Status: Terminated
• First Posted: December 28, 2018
• Last Update Posted: January 27, 2021
• Sponsor: CMC Ambroise Paré
• Information provided by (Responsible Party): CMC Ambroise Paré

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	Not Applicable

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 (Clinical Trial)
• 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: February 22, 2019
• Actual Primary Completion Date: August 21, 2020
• Actual Study Completion Date: September 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

Outcome Measures

Primary Outcome Measures :

1. Hemodynamic response [ Time Frame: During the optimization session ]
   Highest Systolic Blood Pressure (SBP) obtained by stimulation vector

Secondary Outcome Measures :

1. echocardiographic response [ Time Frame: at 6 months of follow-up ]
   Left Ventricular Ejection Fraction (LVEF), Left Ventricular end-diastolic Volume (LVEDV), Left Ventricular End-Systolic Volume (LVESV)
2. Clinical response [ Time Frame: at 6 months of follow up ]
   Hospitalization for heart failure

Eligibility Criteria

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

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

Contacts and Locations

Locations

France

CMC Ambroise Paré

Neuilly-sur-Seine, Ile De France, France, 92200

GHEM Eaubonne

Montmorency, France, 95160

CHU de Poitiers

Poitiers, France, 86021

Sponsors and Collaborators

CMC Ambroise Paré

More Information

• Responsible Party: CMC Ambroise Paré
• ClinicalTrials.gov Identifier: NCT03789487
• Other Study ID Numbers: 2018/09
• First Posted: December 28, 2018
• Last Update Posted: January 27, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CMC Ambroise Paré:

Cardiac Resynchronization Therapy; Non-responders; Pacing vector optimization; Atrioventricular delay optimization; Non invasive hemodynamic optimization; Heart Failure

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases