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Revisit the Value of Imaging in Best Using CArdiac Resynchronization Therapy (RICART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02528032
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : September 12, 2018
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
Many studies have shown the benefits of cardiac resynchronization therapy (CRT) with biventricular pacing in patients with heart failure with left ventricular dysfunction. CRT restores contraction coordination between different regions of the left ventricle, which yields a significant improvement in LV systolic function, symptoms, exercise tolerance and quality of life. In the longer term, treatment with resynchronization induces a reverse remodeling of the left ventricle and a decrease in mortality and morbidity (hospitalization for heart failure). Nevertheless, even if a majority of patients treated with CRT feel the benefit, some (up to 40% depending on the response criteria of CRT) do not experience significant improvement (nonresponders). Echocardiography and imaging have not so far demonstrated their added value to optimize delivery of CRT. Monocentric promising work on limited numbers of patients, however, were carried out. Meanwhile, equipment for delivering CRT evolves and new probes with four poles stimulation of the left ventricle are now used. The objective of this research is to validate new sequences of ultrasound processing estimating the CRT. These tools are based on usual echocardiographic examination of patients

Condition or disease Intervention/treatment Phase
Cardiac Resynchronization Therapy Other: Echographic evaluation of heart function Not Applicable

Detailed Description:

Pilot study for testing tools pre and post-treatment images echocardiography but also MRI with a descriptive purpose and identification of the computed parameters should be secondarily test a large multicenter cohort . Patients in the study will be explored in RICART preimplantation as then in the manner used in current clinical routine. The use of data by cons will focus on the study of new tools ever compared in the same patients.

Data echocardiography (as with other techniques) are those used in clinical routine. Then, the data processing to be carried characterized the asynchrony posteriori, regardless of initial clinical data on a dedicated search software. Each quantitative parameter will be compared with others in order to predict the response to resynchronization. Response prediction of threshold values to the resynchronization can be obtained and compared to each of the tools. The value of relative and an addition to another may be tested.

The predictive value of the change (delta) of each parameter between the pre- and post-implantation to predict response to al resynchronization, will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Revisit the Value of Imaging in Best Using CArdiac Resynchronization Therapy
Study Start Date : August 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : September 2018

Arm Intervention/treatment
Echocardiographic evaluation
Echocardiographic evaluation of heart function with new processing tools
Other: Echographic evaluation of heart function
Echocardiographic data collection and analysis, not fully exploited at present

Primary Outcome Measures :
  1. Measuring the prognostic value of a package of new ultrasonic signal processing tools [ Time Frame: pre-implantation ]
    To evaluate the prognostic value of a package of new tools quantitatively measuring mechanical dyssynchrony prior to implantation of a resynchronization pacemaker in terms of favorable response at 6 months.

Secondary Outcome Measures :
  1. Compare pre and post-implantation asynchrony characterisation [ Time Frame: pre-implantation, and within three day post implantation ]
    pre and within three day post implantation mechanical asynchrony by package of new tools will be compared with the same characterization of biventricular pacemaker.

  2. Characterization of the pre-implantation mechanical asynchrony by package of new tools [ Time Frame: pre-implantation ]

    The characterization of the pre-implantation mechanical asynchrony with the package of tested tools will be correlated with the results of:

    • Replacement fibrosis mark (taking gadolinium) and interstitial fibrosis (T1 mapping) [MRI]
    • Evaluation of the coronary venous system by chest CT

  3. Analysis and comparison of cardiac mechanical asynchrony characterization tools with other asynchronism criteria already describe [ Time Frame: at 6 month ]
    cardiac mechanical asynchrony characterization tools will be analyzed and compared, associated with other asynchronism criteria already described defined by the reverse LV remodeling 6 months post-implantation (positive response regressions = ≥15% of tele-systolic volumes VG 6 months) to define the best or the best combination of predictive tools of the response to the CRT)

  4. Prediction score [ Time Frame: at 6 month ]
    definition of a prediction score of the answer to the CRT (echocardiographic and multi-modality)

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

Inclusion Criteria:

  • Any patient with sinus rhythm sent to hospital for a cardiac resynchronization according to ESC criteria and implanted with a left ventricular pacing lead quadrupole

Exclusion Criteria:

  • Patients with an acoustic window is incompatible with the accurate echographic assessment of heart function
  • Patients with spontaneous one year prognosis is not dependent on his heart or another disease to the forefront (eg neoplasia)
  • Contra-indications to MRI (pacemaker or implantable defibrillator, intracranial ferromagnetic surgical clips, cochlear implants, intraocular metallic foreign body, Starr-Edwards heart valve prosthesis pre 6000, biomedical device type pump insulin or neurostimulator) or against -indications to iodinated contrast injection (severe renal impairment, allergy).
  • Patient not giving free and informed consent.

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 identifier (NCT number): NCT02528032

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CHU Pontchaillou
Rennes, France, 35000
Sponsors and Collaborators
Rennes University Hospital
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Principal Investigator: Erwan Donal, MD/PH/Prof Rennes UH

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Responsible Party: Rennes University Hospital Identifier: NCT02528032     History of Changes
Other Study ID Numbers: 35RC14-9767
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2016
Keywords provided by Rennes University Hospital:
Left ventricular dysfunction
Other cardiac dysrhythmias