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Completed

NCT Number: NCT02528032

Revisit the Value of Imaging in Best Using CArdiac Resynchronization Therapy

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

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Key information

Conditions

Cardiac Resynchronization Therapy Cardiovascular Diseases Heart Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Pontchaillou

Rennes, 35000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Echographic evaluation of heart function

Other

Echocardiographic data collection and analysis, not fully exploited at present

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: RICART

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 19, 2015
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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