Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical and Device Functional Assessment of Real World ICD Patients (CARAT)

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.
 
ClinicalTrials.gov Identifier: NCT02341768
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
MicroPort CRM

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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).


Condition or disease Intervention/treatment
Arrythmia Implantable Cardioverter Defibrillator Device: ICD

Detailed Description:

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:

  • Clinical parameters, like patient demographics and history, procedural and hospital discharge data, as well as the short and long term serious adverse events (death and hospitalization)
  • Device parameters, such as delivered shocks, ATP, or other device therapies

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 2056 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Device Functional Assessment of Real World ICD Patients
Actual Study Start Date : June 2015
Actual Primary Completion Date : November 26, 2019
Actual Study Completion Date : November 26, 2019
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: ICD
    ICD single, dual or triple chamber, upgrade, replacement or primo implant

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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) [ Time Frame: 2 years ]
    Incidence of all death, device and/or cardiac related hospitalization at 24 months post implant


Secondary Outcome Measures :
  1. 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. [ Time Frame: at implantation or hospital discharge ]
    as reported by the sites on the AE eCRF

  2. The incidence of all death, device and/or cardiac related hospitalization at 12 months post implant (evaluated with a survival curve) [ Time Frame: at 12 months ]
    as reported by the sites with AE

  3. The predictors of mortality and cardiac related hospitalization at 12 and 24 months [ Time Frame: at 12 and 24 months ]
    as reported by the sites with AE and medical history information

  4. The predictors of appropriate or inappropriate therapies (ATP and shocks) at 12 and 24 months, as verified by a dedicated committee [ Time Frame: at 12 and 24 months ]
    based on therapies delivered recorder on device file, and verified by a dedicated committee

  5. 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) [ Time Frame: at implant ]
    based on the patient's medical history and reason for implant as reported by the investigators


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Patient Implanted (first implant, replacement, upgrade) with a Sorin Group ICD/CRT-D device, according to current available guidelines and IFU
  • Signed and dated informed consent (in accordance to local regulation)

Exclusion Criteria:

  • Already included in another clinical study that could confound the results of this study
  • Not available for routine follow-up visits
  • Minor age
  • Drug addiction or abuse
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02341768


Locations
Show Show 102 study locations
Sponsors and Collaborators
MicroPort CRM
Investigators
Layout table for investigator information
Principal Investigator: Javier Moreno, Dr Hospital Ramón y Cajal Ctra. de Colmenar Viejo km 9.100, 28034 Madrid, Spain
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: MicroPort CRM
ClinicalTrials.gov Identifier: NCT02341768    
Other Study ID Numbers: RTSY03
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Keywords provided by MicroPort CRM:
clinical and device functional information
"real world" ICD patient population
Additional relevant MeSH terms:
Layout table for MeSH terms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes