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OpenTrials
Completed

NCT Number: NCT02341768

Clinical and Device Functional Assessment of Real World ICD Patients

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).

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Key information

Conditions

Arrythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Implantable Cardioverter Defibrillator Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH Feldkirch, Feldkirchen bei Mattighofen, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ICD

Device

ICD single, dual or triple chamber, upgrade, replacement or primo implant

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

MicroPort CRM

Industry

Registry information

Acronym: CARAT

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 19, 2015
Registry last updated
Aug 17, 2020

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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