Observational Study on Inappropriate Therapies

MicroPort CRM881 enrolled

Overview

The purpose of the study is to assess the incidence of inappropriate shocks at 2 years, in a population of patients undergoing a generator replacement (VR/DR/CRT) or upgrade from a previously implanted ICD (VR/DR)

All subjects will be included during an inclusion visit (within 7 days post generator replacement or upgrade), and followed up at a post replacement visit (1 - 6 months post replacement or upgrade), at 12, 18 and 24 months post replacement or upgrade. These follow-up visits will be performed in-clinic except for the 18 months post replacement or upgrade visit, which could be performed through device remote monitoring. Additional follow-ups can be performed at physician's discretion. Data on reportable adverse events will be collected throughout the study. All study data will be collected using an EDC system. All delivered anti-tachycardia therapies (shock or ATP) will be reviewed by an independent board of experts in order to evaluate appropriateness. The programming of the device parameters is at physician's discretion (suggested settings is slow VT monitoring zone 150 - 185 bpm with 30 cycles persistence, VT zone 185 - 230 bpm with 16 cycles persistence, remote monitoring activated).

Study Type

OBSERVATIONAL

Enrollment

881

Conditions

Inappropriate Shocks From Implanted Defibrillator ICD Replacement or Upgrade

Interventions

ICD replacement or upgradeDEVICE

Currently, it is common for patients to survive beyond their initial prophylactic ICD generator. It is unclear whether further benefit related to inappropriate shocks or ATP is derived from long-term device therapy, particularly if there has been a change in the patient's cardiovascular condition.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Any subject that had an ICD/CRT-D replacement/upgrade according to the latest relevant clinical guidelines with a MicroPort CRM ICD / CRT-D for less than 7 days 2. Signed and dated the informed consent form Exclusion Criteria: 1. RV lead replacement 2. Previous ICD/CRT-D inactivated or already explanted 3. Active myocarditis 4. Primary prevention for Arrhythmogenic Ventricular Cardiomyopathy, Ion channelopathies, Hypertrophic Cardiomyopathy and Infiltrative or Inherited Cardiomyopathy. 5. Heart transplant (done or on waiting list) or implanted with a ventricular assist device (VAD) 6. Already included in an Interventional study that could confound the results of this study 7. Inability to understand the purpose of the study or to meet follow-up visits as defined in the investigational plan 8. Minor age (\<18 years) or under guardianship or kept in detention 9. Ongoing drug or alcohol addiction or abuse which would interfere with the subject's ability to be compliant with the study. 10. Life expectancy less than 1 year 11. Pregnant or breast feeding

Locations (58)

Outcomes

Primary Outcomes

Incidence of inappropriate shocks

This endpoint will assess the incidence of inappropriate shocks, in a population of patients undergoing a generator replacement (VR/DR/CRT) or upgrade from a previously implanted ICD (VR/DR).

Time frame: 2 years after replacement or upgrade

Data from ClinicalTrials.gov

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Broward Health Medical Center

Fort Lauderdale, Florida, United States

The University of Chicago Medicine Hospital

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Rutgers New Jersey Medical School

Newark, New Jersey, United States

St. Mary Medical Center

Langhorne, Pennsylvania, United States

Universitätsklinik Innsbruck - Kardiologie und Angiologie

Innsbruck, Austria

Akademisches Krankenhaus Wien

Vienna, Austria

Landesklinikum Wiener Neustadt

Wiener Neustadt, Austria

UZ Brussel

Jette, Belgium

UCL Mont-Godinne

Yvoir, Belgium

...and 48 more locations