Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients (OPTIREG)
Primary Purpose
Heart Failure, Cardiac Resynchronization Therapy
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Device programming of CRT pacemaker or defibrillator
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Cardiac Resynchronization Therapy, Non-responders, Pacing vector optimization, Atrioventricular delay optimization, Non invasive hemodynamic optimization, Heart Failure
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
Sites / Locations
- CMC Ambroise Paré
- GHEM Eaubonne
- CHU de Poitiers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Non-responders to CRT
Arm Description
Non-responders to CRT who will undergo an electrical optimization of the settings of their device
Outcomes
Primary Outcome Measures
Hemodynamic response
Highest Systolic Blood Pressure (SBP) obtained by stimulation vector
Secondary Outcome Measures
echocardiographic response
Left Ventricular Ejection Fraction (LVEF), Left Ventricular end-diastolic Volume (LVEDV), Left Ventricular End-Systolic Volume (LVESV)
Clinical response
Hospitalization for heart failure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03789487
Brief Title
Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients
Acronym
OPTIREG
Official Title
Prospective Multicentric Study of Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
the end of inclusion period
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
August 21, 2020 (Actual)
Study Completion Date
September 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CMC Ambroise Paré
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiac Resynchronization Therapy
Keywords
Cardiac Resynchronization Therapy, Non-responders, Pacing vector optimization, Atrioventricular delay optimization, Non invasive hemodynamic optimization, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-responders to CRT
Arm Type
Experimental
Arm Description
Non-responders to CRT who will undergo an electrical optimization of the settings of their device
Intervention Type
Device
Intervention Name(s)
Device programming of CRT pacemaker or defibrillator
Intervention Description
Stimulation vector optimization then AV delay optimization in order to obtain the highest systolic blood pressure (SBP) by using the Finapress® NOVA noninvasive device
Primary Outcome Measure Information:
Title
Hemodynamic response
Description
Highest Systolic Blood Pressure (SBP) obtained by stimulation vector
Time Frame
During the optimization session
Secondary Outcome Measure Information:
Title
echocardiographic response
Description
Left Ventricular Ejection Fraction (LVEF), Left Ventricular end-diastolic Volume (LVEDV), Left Ventricular End-Systolic Volume (LVESV)
Time Frame
at 6 months of follow-up
Title
Clinical response
Description
Hospitalization for heart failure
Time Frame
at 6 months of follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CMC Ambroise Paré
City
Neuilly-sur-Seine
State/Province
Ile De France
ZIP/Postal Code
92200
Country
France
Facility Name
GHEM Eaubonne
City
Montmorency
ZIP/Postal Code
95160
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients
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