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

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ClinicalTrials.gov Identifier: NCT03789487
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
CMC Ambroise Paré

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Estimated Primary Completion Date : August 21, 2020
Estimated Study Completion Date : March 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789487


Contacts
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Contact: MOUBARAK Ghassan, MD (+33) 1 46 39 50 79 gmoubarak@rythmologie.paris

Locations
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France
CMC Ambroise Paré Recruiting
Neuilly-sur-Seine, Ile De France, France, 92200
Contact: Ghassan A Moubarak, MD    +33146415079      
Principal Investigator: Ghassan Moubarak, MD         
Sub-Investigator: Verginie Ferchaud, MD         
Sponsors and Collaborators
CMC Ambroise Paré

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Responsible Party: CMC Ambroise Paré
ClinicalTrials.gov Identifier: NCT03789487     History of Changes
Other Study ID Numbers: 2018/09
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases