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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Montmorency, France, 95160
- GHEM Eaubonne
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Poitiers, France, 86021
- CHU de Poitiers
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Ile De France
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Neuilly-sur-Seine, Ile De France, France, 92200
- CMC Ambroise Paré
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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
|
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
Time Frame: During the optimization session
|
Highest Systolic Blood Pressure (SBP) obtained by stimulation vector
|
During the optimization session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
at 6 months of follow-up
|
|
Clinical response
Time Frame: at 6 months of follow up
|
Hospitalization for heart failure
|
at 6 months of follow up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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