An observational study in Arrythmia and Implantable Cardioverter Defibrillator, sponsored by MicroPort CRM. Completed at 102 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-17.
Sponsored by MicroPort CRM · Observational
The primary requirement of the implantable cardioverter defibrillator (ICD) is to preserve life by terminating life-threatening arrhythmias (VT/VF). The treatment options vary in terms of techniques and medical devices, based on the patient's condition.
It is extremely important in the clinical practice to identify which patients' subgroup benefits the most from the ICD therapy, which comorbidity has a major impact on the patients' prognosis, or which pre-intra-post procedural behaviors provoke less complications, and affect the patient's outcome (including prolonged or unwanted hospitalizations).
For these reasons, it is very important to observe the clinical practice on a large variety of centers and countries, with the objective to collect long term safety and performance data in patients undergoing ICD/CRT-D device implantation (first implant, replacement or upgrade).
The safety and performance of the ICDs can be evaluated through the collection of multiple parameters such as, but not limited to:
Worldwide selected centers will be invited to participate in this prospective study and include their "real-world" patients treated with Sorin Group commercially available ICDs and CRT-Ds devices.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's enrollment of 2,056 is above the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →MicroPort CRM is the lead sponsor of 24 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The aim of this study is to include all patients from a global "real world" (standard of care) population at participating centers and will reference the indication and the contra-indications specified in the guidelines and IFUs.
Exclusion Criteria:
ICD single, dual or triple chamber, upgrade, replacement or primo implant
Evaluate clinical and device functional information from "real world" ICD patient population following standard of care at participating centers w/in the different participating countries (Incidence of all death, device,cardiac related hospitalization)
Incidence of all death, device and/or cardiac related hospitalization at 24 months post implant
Time frame: 2 years
Serious procedural complications or other SAE at implantation or hospital discharge. The data analyzed are those collected from the day of implantation to the day of hospital discharge, with an expected average of 1 week.
as reported by the sites on the AE eCRF
Time frame: at implantation or hospital discharge
The incidence of all death, device and/or cardiac related hospitalization at 12 months post implant (evaluated with a survival curve)
as reported by the sites with AE
Time frame: at 12 months
The predictors of mortality and cardiac related hospitalization at 12 and 24 months
as reported by the sites with AE and medical history information
Time frame: at 12 and 24 months
The predictors of appropriate or inappropriate therapies (ATP and shocks) at 12 and 24 months, as verified by a dedicated committee
based on therapies delivered recorder on device file, and verified by a dedicated committee
Time frame: at 12 and 24 months
The evolution of the indication for implant according to guideline (based on the patient's medical history and reason for implant as reported by the investigators)
based on the patient's medical history and reason for implant as reported by the investigators
Time frame: at implant
Showing the first 100 of 102 sites across 12 countries.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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