Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients

NCT ID: NCT03789487

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-22
• Study Completion Date: 2020-09-14

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.

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.

Conditions

Heart Failure; Cardiac Resynchronization Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-responders to CRT

Non-responders to CRT who will undergo an electrical optimization of the settings of their device

Group Type: EXPERIMENTAL

Device programming of CRT pacemaker or defibrillator

Intervention Type: DEVICE

Stimulation vector optimization then AV delay optimization in order to obtain the highest systolic blood pressure (SBP) by using the Finapress® NOVA noninvasive device

Interventions

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CMC Ambroise Paré

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GHEM Eaubonne

Montmorency, , France

CHU de Poitiers

Poitiers, , France

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, France

Countries

France

Other Identifiers

2018/09

Identifier Type: -

Identifier Source: org_study_id