Clinical and Device Functional Assessment of Real World ICD Patients

Completed

• Conditions: Implantable Cardioverter Defibrillator; Arrythmia

• Registration Number: NCT02341768
• Lead Sponsor: MicroPort CRM

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).

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 Timeline

• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-19
• Study Start: 2015-06
• Primary Completion: 2019-11-26
• Study Completion: 2019-11-26
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-14
• Last Update Posted: 2020-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2056

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	2 years	Incidence of all death, device and/or cardiac related hospitalization at 24 months post implant

Secondary Outcome Measures

Name	Time	Method
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.	at implantation or hospital discharge	as reported by the sites on the AE eCRF
The incidence of all death, device and/or cardiac related hospitalization at 12 months post implant (evaluated with a survival curve)	at 12 months	as reported by the sites with AE
The predictors of mortality and cardiac related hospitalization at 12 and 24 months	at 12 and 24 months	as reported by the sites with AE and medical history information
The predictors of appropriate or inappropriate therapies (ATP and shocks) at 12 and 24 months, as verified by a dedicated committee	at 12 and 24 months	based on therapies delivered recorder on device file, and verified by a dedicated committee
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)	at implant	based on the patient's medical history and reason for implant as reported by the investigators

Trial Locations

Locations (101)

LKH Feldkirch; 🇦🇹 Feldkirchen bei Mattighofen, Austria

LKH Innsbruck; 🇦🇹 Innsbruck, Austria

Kepler Universitatsklinikum GmbH; 🇦🇹 Linz, Austria

LKH St. Polten; 🇦🇹 Polten, Austria

Sunnybrook Health Sciences Center; 🇨🇦 Toronto, Ontario, Canada

Royal Alexandra Hospital; 🇨🇦 Edmonton, Canada

HDM (CHUM) Montreal; 🇨🇦 Montreal, Canada

HSCM Montreal; 🇨🇦 Montreal, Canada

IUCPQ Quebec; 🇨🇦 Quebec, Canada

Sherbrooke; 🇨🇦 Quebec, Canada

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