Biventricular Pacemakers, Artificial, Cardiac Resynchronization, Cardioverter-Defibrillators, Implantable, Device Replacement
Conditions
Keywords
CRT-D, replacement, primary prevention, ventricular tachyarrhythmias
Brief summary
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
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.
Interventions
DEVICECRT-D device replacement
Sponsors
Biotronik SE & Co. KG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the rate of patients with at least one sustained VTA after replacement | up to two years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with at least one VTA for 4 specific subgroups | After the device replacement and after a minimum of two years follow-up (FU) | 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 |
Other
| Measure | Time frame |
|---|---|
| Rate of patients with ventricular tachycardia or ventricular fibrillation events, with appropriate therapies | After the device replacement and after a minimum of two years FU |
| Rate of patients with inappropriate therapies/diagnosis | After the device replacement and after a minimum of two years FU |
| Baseline factor predictors of ventricular events | After the device replacement and after a minimum of two years FU |
| Serious adverse events related to ventricular events / inappropriate therapies | After the device replacement and after a minimum of two years FU |
Countries
Belgium, France, Germany, Hungary, Israel, Italy, Portugal, Spain
Outcome results
None listed