Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication

Study Overview
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Brief Summary
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Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for defibrillator back-up after an event-free first CRT-D service-life for patients with improved LVEF is a controversy question. 80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention do not experience VTA during the life-time of their first device. So, regarding patients implanted with a CRT-D for primary prevention at the time of first implantation, the question is will they experience VTA after their device replacement by another CRT-D.

Detailed Description
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The objective of this study is to describe, in a population of patients who had a primary prevention ICD indication at first implantation of a CRT-D, the relevance defibrillator back-up after the replacement of the first CRT-D. For that, the rate of patients with at least one sustained VTA detected by the CRT-D or a conventional surface ECG will be assessed after the device replacement. Furthermore, the association between the baseline characteristics of the CRT-D population after replacement and the risk of subsequent VTA will be explored after a minimum of two years FU.

Official Title
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BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication

Conditions
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Biventricular Pacemakers, Artificial, Cardiac Resynchronization, Cardioverter-Defibrillators, Implantable, Device Replacement

Intervention / Treatment
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* Device: CRT-D device replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with primary prevention indication for defibrillation at the time of the first CRT-D implantation Patient implanted as first replacement by a CRT-D device (CRT-D by CRT-D) Lifetime of the previous CRT-D > 3 years Patient willing and able to comply with the protocol and who has provided written informed consent Patient whose medical situation is stable. Exclusion Criteria: Patient with an ICD lead under advisory (e.g. Fidelis lead) Right or left ventricular leads exchange during CRT-D replacement Non functional atrial (except for patient with chronic AF) or right/left ventricular leads Life expectancy < 1 year Age < 18 years Pregnant woman or woman who plan to become pregnant during the trial Participation in another interventional clinical study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CRT-D device replacement|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the rate of patients with at least one sustained VTA after replacement |  | up to two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with at least one VTA for 4 specific subgroups | Grp R[1-4]: LVEF ≥40% / <40% at the time of replacement and with / without previous VTA during the lifetime of their first CRT-D device | After the device replacement and after a minimum of two years follow-up (FU) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRT-D, replacement, primary prevention, ventricular tachyarrhythmias