Revisit the Value of Imaging in Best Using CArdiac Resynchronization Therapy (RICART)
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|ClinicalTrials.gov Identifier: NCT02528032|
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : September 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Resynchronization Therapy||Other: Echographic evaluation of heart function||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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
- 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)
- Prediction score [ Time Frame: at 6 month ]definition of a prediction score of the answer to the CRT (echocardiographic and multi-modality)
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): NCT02528032
|Rennes, France, 35000|
|Principal Investigator:||Erwan Donal, MD/PH/Prof||Rennes UH|